510(k) K203652
- Device
- Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,
- Applicant
- JKH USA, LLC
- 510(k) number
- K203652
- Product code
- DXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-06
- Date received
- 2020-12-14
- 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
- No
Applicant Contact#
- Contact
- Bill Quanqin Dai
- Address
- 20505 Valley Blvd. Suite 108 Walnut CA US 91789 91789
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#
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 |
| K251045 | Disposable 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases