WELCH ALLYN, INC.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1316463	1316463	WELCH ALLYN, INC.	1	Y	2026-01-01	4341 STATE STREET RD. Skaneateles Falls NY US 13153
1316463	1316463	WELCH ALLYN, INC.	1	Y	2020-04-25	4341 STATE STREET RD. Skaneateles Falls NY US 13153
2183461	2183461	Welch Allyn, Inc.	1	N	2020-04-25	7865 NORTH 86TH ST. MILWAUKEE WI US 53224

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
225678	1068985771	K974149	AMBULATORY X-12 TELEMETRY MODULE	DRG	1998-01-08
188431	1532056017	K972121	ACUITY CENTRAL STATION	MLD	1997-11-07
188431	1068960494	K955635	VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND	HEX	1996-05-07
188431	1105285183	K951246	PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS	FLS	1996-02-02
301400	1672544204	K950461	WELCH ALLYN OPHTHALMOSCOPE	HLI	1995-04-04
188431	1706262343	K950461	WELCH ALLYN OPHTHALMOSCOPE	HLI	1995-04-04
225678	1213145082	K945985	PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400	DQK	1995-07-03
188431	1107765938	K945071	PROPAQ 200 MONITOR	DRT	1995-05-10
188431	1223490972	K940493	HAND ANEROID SPHYGMOMANOMETER	DXQ	1994-07-01
188431	1302589906	K935609	4002 INFANT SCALE FOR INCUBATORS AND WARMERS	FMT	1994-07-01
188431	1072087295	K930604	BALANCED(TM) NYLON BLADDER	DXQ	1993-04-30
301400	1228489391	K930604	BALANCED(TM) NYLON BLADDER	DXQ	1993-04-30
225678	1393277770	K930558	MORTARA INSTRUMENT, INC. E-SCRIBE	DPS	1993-04-27
188431	1119950133	K930023	MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE	HLI	1993-06-21
301400	1367767271	K930023	MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE	HLI	1993-06-21
188431	1405614014	K902730	SPO2 OPTION	DQA	1990-10-22
301400	1186321623	K884421	PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT	DXQ	1989-01-13
188431	1977784486	K884421	PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT	DXQ	1989-01-13
188431	1350137177	K861516	WELCH ALLYN TYMPANOMETER	ETY	1986-06-10
301400	1622606206	K861516	WELCH ALLYN TYMPANOMETER	ETY	1986-06-10
301400	1331560134	K810227	MODEL #53110 DISPOSABLE ANOSCOPE	FER	1981-02-19
188431	1981870125	K810227	MODEL #53110 DISPOSABLE ANOSCOPE	FER	1981-02-19
301400	1253908500	K790610	SIGMOIDOSCOPE TIPLESS	FAM	1979-04-23
188431	1759727605	K790610	SIGMOIDOSCOPE TIPLESS	FAM	1979-04-23
225678	1091565076	K781430	PREGELLED DISPOSABLE E.K.G. ELECTRODE	DRX	1978-10-31
188431	1041603510	K771900	71110 DESK CHARGER	HLS	1977-11-09
301400	1121028575	K771864	WALL TRANSFORMERS 74710 & 74910	GCW	1977-11-22
188431	1961456979	K771864	WALL TRANSFORMERS 74710 & 74910	GCW	1977-11-22
301400	1162593877	K770906	ANOSCOPE, OPTIC, FIBER	FER	1977-06-01
188431	1596846834	K770906	ANOSCOPE, OPTIC, FIBER	FER	1977-06-01
188431	1750406458	K770768	OPHTHALMOSCOPE, MODEL #11100	HLI	1977-05-06
301400	2004276712	K770768	OPHTHALMOSCOPE, MODEL #11100	HLI	1977-05-06
301400	1119984674	K770291	SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125	FAM	1977-02-18
188431	1832393054	K770291	SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125	FAM	1977-02-18
301400	1878909856	K251745	Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)	DXQ	2025-12-16
301400	1294216103	K243598	Welch Allyn Connex® 360 (Multiple)		2025-07-13
301400	1301975121	K241411	Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)	MWI	2024-12-20
301400	1137950262	K223381	iExaminer System with Panoptic Plus	HKI	2023-03-15
301400	1881115596	K212473	Welch Allyn Connex Central Station	MWI	2022-10-28
225678	1190618994	K191013	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option	BZG	2019-09-10
301400	1425281837	K191013	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option	BZG	2019-09-10
225678	1344474049	K182297	Surveyor S2	DRG	2019-01-24
301400	1954100216	K181720	Epiphany Cardio Server Mobile	DQK	2018-07-30
188431	1117479253	K181016	Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System	NFJ	2018-07-16
301400	1444068202	K181016	Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System	NFJ	2018-07-16
301400	1051165059	K173765	Surveyor Patient Monitor	MHX	2018-09-04
301400	1312470831	K171621	Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor	MHX	2017-06-30
301400	1239897990	K170037	Breathe Technologies Life2000 Ventilation System	CBK	2017-08-11
225678	1066899702	K161465	CardioConfirm	DQK	2016-09-03
225678	1916549036	K160685	Surveyor S4 Mobile Monitor	MHX	2016-08-04
225678	1379621278	K152944	Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems	DPS	2016-01-06
301400	1772748781	K152944	Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems	DPS	2016-01-06
301400	1187998162	K152748	Braun Thermoscan PRO 6000 Ear Thermometer	FLL	2016-03-01
188431	2066928816	K152748	Braun Thermoscan PRO 6000 Ear Thermometer	FLL	2016-03-01
225678	1507404205	K152626	H3+ Holter Recorder	MWJ	2016-02-26
301400	1859874371	K152626	H3+ Holter Recorder	MWJ	2016-02-26
301400	1056118809	K142356	Connex Spot Monitor,901058 Vital Signs Monitor Core	MWI	2014-12-19
188431	1895712976	K142356	Connex Spot Monitor,901058 Vital Signs Monitor Core	MWI	2014-12-19
301400	1729447919	K142105	ELI 380 ELECTROCARDIOGRAPH	DPS	2014-09-05
225678	1988900869	K142105	ELI 380 ELECTROCARDIOGRAPH	DPS	2014-09-05
225678	1125552235	K141811	MORTARA MONITORING WAVEFORM VIEWER	MHX	2014-11-19
188431	1063307305	K141582	CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION	DPS	2014-07-11
301400	1766633364	K141582	CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION	DPS	2014-07-11
225678	1504075235	K133989	AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM	DXN	2014-11-25
188431	1371046597	K132808	VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR	MWI	2013-11-20
188431	1106370151	K132807	MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)	MWI	2014-01-31
301400	1250747314	K132807	MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)	MWI	2014-01-31
225678	1106582946	K131929	SURVEYOR CENTRAL STATION	MHX	2013-12-03
225678	1266034028	K123556	MORTARA SURVEYOR PATIENT MONITOR	MHX	2013-03-22
301400	1603225917	K122401	TANGO M2 BLOOD PRESSURE MONITOR	DXN	2012-11-02
301400	1003118657	K122073	ELI 280 ELECTROCARDIOGRAPH	DPS	2012-08-02
225678	1521969676	K122073	ELI 280 ELECTROCARDIOGRAPH	DPS	2012-08-02
301400	1466887703	K122058	FLEXIPORT ECOCUFF	DXQ	2012-11-05
188431	1546727526	K122058	FLEXIPORT ECOCUFF	DXQ	2012-11-05
301400	2018334217	K121405	PANOPTIC	HKI	2012-12-20
188431	2044920862	K121405	PANOPTIC	HKI	2012-12-20
188431	1419863126	K121013	CONNEX VITAL SIGNS MONITOR 6000 SERIES	MWI	2012-07-26
301400	1034876441	K120865	RSCRIBE ELECTROCARDIOGRAPH	DPS	2012-07-19
225678	1074329346	K120865	RSCRIBE ELECTROCARDIOGRAPH	DPS	2012-07-19
188431	1243973981	K120774	ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT	DSI	2012-04-10
188431	1674840870	K120743	SPECULUM, VAGINAL, NONMETAL	HIB	2012-03-23
188431	1260985352	K120343	CONNEX WORKSTATION	MWI	2012-02-24
188431	1899187755	K112687	CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES	MWI	2011-11-22
225678	1366521907	K102206	ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10	DPS	2011-02-18
301400	1126576437	K101680	WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES	DXN	2010-07-09
188431	1615258026	K101680	WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES	DXN	2010-07-09
301400	1504386405	K101403	ELI 250 ELECTROCARDIOGRAPH	DPS	2010-07-02
225678	1782549132	K101403	ELI 250 ELECTROCARDIOGRAPH	DPS	2010-07-02
301400	1283240081	K101115	ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150	DPS	2010-06-18
225678	2043594202	K101115	ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150	DPS	2010-06-18
225678	1128605463	K100127	ELI 230 ELECTROCARDIOGRAPH	DPS	2010-04-16
301400	2024921149	K100127	ELI 230 ELECTROCARDIOGRAPH	DPS	2010-04-16
225678	1302641842	K093339	ELI PC ELECTROCARDIOGRAPH	DPS	2010-02-19
225678	1419955413	K093211	CARECENTER MD	DPS	2010-06-03
225678	1368171417	K092663	ELI 350 ELECTROCARDIOGRAPH	DPS	2009-12-14
301400	1139128819	K082478	WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62	BZG	2009-03-09
188431	1294330815	K082478	WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62	BZG	2009-03-09
225678	1898482664	K081800	T12S TELEMETRY TRANSMITTER	DQA	2008-09-24
188431	1504308200	K081160	AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES	FLL	2008-06-24
225678	1543864340	K080605	SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL	DSA	2008-05-05
188431	1685579337	K080189	TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX	DXQ	2008-08-15
301400	1997493657	K080189	TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX	DXQ	2008-08-15
188431	1180424890	K072449	CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS	DPS	2007-11-29
188431	2062848284	K070204	LINK TO ACUITY CLINICIAN NOTIFIER	MSX	2007-03-23
188431	1626137425	K070060	WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)	DXQ	2007-12-18
301400	1750073315	K070060	WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)	DXQ	2007-12-18
188431	1916510598	K063419	MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )	MWI	2006-12-04
188431	1251724320	K053381	WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE	DQA	2006-06-15
301400	1537674016	K053381	WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE	DQA	2006-06-15
301400	1770665028	K053078	ERGOSELECT 100 K/P, ERGOSELECT 200 K/P	ISD	2006-04-27
188431	1475353031	K053027	VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)	MWI	2005-11-22
301400	1640858346	K052883	CARDIOSERVER	DQK	2005-11-01
188431	1166018666	K052160	ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)	DSI	2005-12-16
188431	1179106842	K051730	MATRIX HOLTER SYSTEM, MODEL M12	MLO	2005-09-26
301400	1369461783	K051730	MATRIX HOLTER SYSTEM, MODEL M12	MLO	2005-09-26
225678	1777233437	K050896	H12+ HOLTER RECORDER	DSH	2005-08-24
301400	1846668565	K050896	H12+ HOLTER RECORDER	DSH	2005-08-24
225678	1235259632	K041607	QUINTON Q-TE; RMS	MHX	2004-07-16
188431	1597062331	K033378	VITAL SIGNS MONITOR, PROPAQ LT	MWI	2004-03-01
225678	1010034734	K032038	PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601	DQK	2003-09-05

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
DPS	23	2016-01-06
DXQ	14	2025-12-16
MWI	13	2024-12-20
HLI	8	2001-01-25
MHX	7	2018-09-04
DXN	6	2014-11-25
DQA	6	2008-09-24
DQK	5	2018-07-30
BZG	4	2019-09-10
FLL	4	2016-03-01
MLO	4	2005-09-26
DRT	4	2002-07-23
FER	4	1981-02-19
FAM	4	1979-04-23
HKI	3	2023-03-15
DSI	3	2012-04-10
DRG	2	2019-01-24
NFJ	2	2018-07-16
MWJ	2	2016-02-26
DSH	2	2005-08-24
FSR	2	2003-08-11
DRX	2	2003-03-28
ETY	2	1986-06-10
GCW	2	1977-11-22
CBK	1	2017-08-11
HIB	1	2012-03-23
DSA	1	2008-05-05
MSX	1	2007-03-23
ISD	1	2006-04-27
MLD	1	1997-11-07
HEX	1	1996-05-07
FLS	1	1996-02-02
FMT	1	1994-07-01
HLS	1	1977-11-09