510(k) K951039
- Device
- BLOOD PRESSURE CUFF 1
- Applicant
- PEDIA PALS, INC.
- 510(k) number
- K951039
- Product code
- DXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-31
- Date received
- 1995-03-06
- Regulation
- 870.1120
- Classification name
- Blood Pressure Cuff
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID L BARNES
- Address
- 3939 International Gateway Columbus OH US 43219 43219
FDA Registration Numbers#
- 3004748541
- 3044994756
- 8022257
- 3012421607
- 3016678045
- 3030446844
- 9615583
- 3005695733
- 3010521050
- 3003074886
- 3020460367
- 3006157842
- 3010272829
- 1832894
- 1000379039
- 1036863
- 3000279201
- 3006552505
- 3012528160
- 3007740533
- 2431166
- 3007307487
- 3013426279
- 3038620598
- 3043226252
- 3009685433
- 3015616170
- 3004488394
- 2412762
- 3006636961
- 3011689956
- 8022890
- 1054713
- 1043214
- 3003622639
- 3005998497
- 3006793151
- 3007699082
- 3008962161
- 3007836437
- 3011209790
- 3016701404
- 1713468
- 3005616800
- 3011529836
- 3008483389
- 3013322724
- 3027135885
- 3009191551
- 3004485927
- 3018101395
- 3014579161
- 3016904853
- 3006087789
- 2028411
- 1422443
- 3003864328
- 3014233600
- 3009560891
- 3016170451
- 3004513970
- 3000126629
- 3013517171
- 3011065399
- 3010880718
- 3002865611
- 3009831876
- 1054241
- 1720747
- 3016452327
- 1000589001
- 3007703436
- 3006252153
- 2435946
- 3004784770
- 3022764531
- 3015997711
- 1055236
- 3017619536
- 3010838917
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026-06-22 |
| 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 |
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