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510(k) K120125

Device
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
510(k) number
K120125
Product code
DXQ  
Decision
Substantially Equivalent (SESE)
Decision date
2012-10-03
Date received
2012-01-17
Regulation
870.1120
Classification name
Blood Pressure Cuff
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
ROBIN MARTIN
Address
8200 W. Tower Ave. Milwaukee WI US 53223 53223

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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