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510(k) K152363

Device
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra Long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
Applicant
PHILIPS MEDICAL SYSTEMS
510(k) number
K152363
Product code
DXQ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-10-27
Date received
2015-08-20
Regulation
870.1120
Classification name
Blood Pressure Cuff
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY KRUITWAGEN
Address
3000 Minuteman Rd. Andover MA US 03104 03104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254287Medline Reusable Blood Pressure CuffMedline Industries, LP2026-06-22
K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation2026-05-06
K253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.2026-02-13
K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.2026-01-09
K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare Corporation2025-12-16
K250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation2025-09-03
K251045Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)Unimed Medical Supplies, Inc.2025-07-15
K242623Disposable Blood Pressure cuff; Reusable Blood Pressure cuffShenzhen Medke Technology Co., Ltd.2024-10-31
K240165Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerWenzhou Longwan Medical Device Factory2024-03-20
K233276Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd.2023-12-21
K232772Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)Shenzhen Plinma Technology Co. , Ltd.2023-11-29
K231961NIBPCuffShenzhen Sino-K Medical Technology Co.,Ltd2023-08-30
K230859Aneroid SphygmomanometerWenzhou Kangshun Medical Devices Co.,Ltd2023-06-28
K230145ONE-CUFGe Medical Systems Information Technologies, Inc.2023-03-14
K222652Aneroid Sphygmomanometer; Single Patient Use Aneroid SphygmomanometerCardicare Company, Ltd.2022-11-28

Legacy Summary#

summary

FDA Review#

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