FDA.reportPublic FDA data

510(k) K092604

Device
LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX
Applicant
Trimline Medical Products Corp.
510(k) number
K092604
Product code
DXQ
Decision
Substantially Equivalent (SESE)
Decision date
2009-10-21
Date received
2009-08-25
Regulation
870.1120
Classification name
Blood Pressure Cuff
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NANCY SKOCYPEC
Address
34 Columbia Ave. Branchburg NJ US 08876 08876

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
K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation2026-05-06
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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
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K242623Disposable Blood Pressure cuff; Reusable Blood Pressure cuffShenzhen Medke Technology Co., Ltd.2024-10-31
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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
K222420Disposable Blood Pressure CuffWenzhou Xikang Medical Instruments Co., Ltd.2022-11-21