Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure Cuff
FDA 510(k) K031416 · Clearmedical, Inc.
510(k) numberK031416
Submission
- Device name
- Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure Cuff
- Applicant
- Clearmedical, Inc.
Bellevue, WA, US - Received
- May 5, 2003
- Decision date
- July 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Other 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033579 | Reprocessed Multiple Clip AppliersNMJ · Traditional | 07/11/2005SE |
| K033578 | Reprocessed Reloadable Cutters, Staplers, and AppliersNLL · Traditional | 07/11/2005SE |
| K033591 | Reprocessed TrocarsKBG · Traditional | 06/03/2005SE |
| K033592 | Reprocessed Surgical Scissors and GraspersGEI · Traditional | 07/27/2004SE |
| K033593 | Reprocessed Single Use Devices Biopsy ForcepsNLU · Traditional | 11/20/2003SE |
| K012622 | Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20NLF · Traditional | 07/03/2002SE |
| K012609 | Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25NLF · Traditional | 07/03/2002SE |
| K012600 | Clearmedical/Nellcor Oxisensor II, Adult, Model D-25/D-25LNLF · Traditional | 07/03/2002SE |
| K012621 | Clearmedical/Hentleigh Deep Vein Thrombosis (DVT) GarmentJOW · Traditional | 02/06/2002SE |
| K012616 | Clearmedical/Huntleigh Foot Garments; Models FG200/LRG (Large), FG200/STD (Standard)…JOW · Traditional | 02/06/2002SE |
Questions and answers
When was Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure Cuff cleared by the FDA?
Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure Cuff (K031416) received a 510(k) decision of Substantially Equivalent on July 15, 2003, 71 days after the submission was received.
What is the product code of K031416?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.