All Purpose Cuff, Model 222APC
FDA 510(k) K051904 · Suntech Medical, Inc.
510(k) numberK051904
Submission
- Device name
- All Purpose Cuff, Model 222APC
- Applicant
- Suntech Medical, Inc.
Morrisville, NC, US - Received
- July 13, 2005
- Decision date
- September 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K160439 | SunTech CT40 Spot-check Vital Signs DeviceDXN · Abbreviated | 07/06/2016SE |
| K151520 | Oscar 2DXN · Abbreviated | 02/19/2016SE |
| K122401 | Tango M2 Blood Pressure MonitorDXN · Special | 11/02/2012SE |
| K080854 | Disposable Blood Pressure Cuff, Model DC100DXQ · Abbreviated | 10/20/2008SE |
| K070750 | 247 BP DeviceDXN · Abbreviated | 05/02/2007SE |
| K060820 | Cycle BP Monitor and Pulse Oximeter, Model 1060DXN · Abbreviated | 06/07/2006SE |
| K053209 | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemDXN · Traditional | 01/05/2006SE |
Questions and answers
When was All Purpose Cuff, Model 222APC cleared by the FDA?
All Purpose Cuff, Model 222APC (K051904) received a 510(k) decision of Substantially Equivalent on September 9, 2005, 58 days after the submission was received.
What is the product code of K051904?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.