510(k) K251045

Device: Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
Applicant: Unimed Medical Supplies, Inc.
510(k) number: K251045
Product code: DXQ
Decision: Substantially Equivalent (SESE)
Decision date: 2025-07-15
Date received: 2025-04-03
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: N

Related Records

Applicant Contact

Contact: Huanyu Zeng
Address: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan District Shenzhen CN

FDA Registration Numbers

3010272829
3006113277
3006636961
3003674698
3015220324
1832894
3014541700
3019388613
3010262192
3034669683
3010157426
3006441164
3003074886
3005536872
3022764531
3013783488
3038620598
2431166
8022257
3033536319
3031192529
1000379039
1937397
1430016
3015997711
2025816
1222630
3011065399
1058002
3015895045
3006769302
8030673
3010698831
9681377
3005616800
1054421
1054241
3003741676
3007703436
3003864328
3009154535
9611500
3015616170
3008573045
9610816
3015007456
3006895660
9615583
3010521050
3004727197
1063285
3009888765
3000279201
3013429557
1055236
3005621440
9680874
3010419931
1720747
3007836437
3017619536
3008483389
3009685433
3004784770
3016170451
3011359729
9680548
3017520431
3008962161
2434008
8022890
3013426279
3014527907
1450057
3043226252
1650347
3003965134
3010880718
3044174020

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DXQ

510(k)	Device	Applicant	Decision date
K260747	YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff	Nihon Kohden Corporation	2026-05-06
K253089	NIBP 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
K253964	Disposable Neonatal NIBP Cuff (U1681S-C51N)	Unimed Medical Supplies, Inc.	2026-01-09
K251745	Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)	Baxter Healthcare Corporation	2025-12-16
K250765	AViTA Arm Type Blood Pressure Monitor Cuff	Avita Corporation	2025-09-03
K242623	Disposable Blood Pressure cuff; Reusable Blood Pressure cuff	Shenzhen Medke Technology Co., Ltd.	2024-10-31
K240165	Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer	Wenzhou Longwan Medical Device Factory	2024-03-20
K233276	Reusable Blood Pressure Cuff	Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	2023-12-21
K232772	Blood 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
K231961	NIBPCuff	Shenzhen Sino-K Medical Technology Co.,Ltd	2023-08-30
K230859	Aneroid Sphygmomanometer	Wenzhou Kangshun Medical Devices Co.,Ltd	2023-06-28
K230145	ONE-CUF	Ge Medical Systems Information Technologies, Inc.	2023-03-14
K222652	Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer	Cardicare Company, Ltd.	2022-11-28
K222420	Disposable Blood Pressure Cuff	Wenzhou Xikang Medical Instruments Co., Ltd.	2022-11-21
K221857	Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201	Zhejiang Lude Technology Development Co., Ltd.	2022-10-13