Arc Adjustable Radial Cuff Compression Device
FDA 510(k) K252772 · Tz Medical, Inc.
510(k) numberK252772
Submission
- Device name
- Arc Adjustable Radial Cuff Compression Device
- Applicant
- Tz Medical, Inc.
Tualatin, OR, US - Received
- September 2, 2025
- Decision date
- May 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
| K222182 | Radial Artery Compression TourniquetsDXC · Traditional | Beijing Demax Medical Technology Co.,Ltd | 01/04/2023SE |
More from Beijing Demax Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K173563 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | 01/10/2018SE |
| K163322 | TZ SKULL PIN AdultHBL · Traditional | 02/23/2017SE |
| K102507 | Area-Ct, TZ Medical Mcot ECG Monitor and Arrhythmia DetectorDSI · Abbreviated | 06/13/2011SE |
| K062577 | V1 Multi-Port Connector, Model Pad V1-MPCDSA · Traditional | 12/15/2006SE |
| K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandQSY · Traditional | 05/11/2004SE |
| K021421 | Padtac Electrophysiology Recording Catheters, Junction Cable Connector & CableDRF · Traditional | 04/18/2003SE |
| K001634 | Cardiosentry Event Monitor, Model 8470-01DXH · Traditional | 12/21/2000SE |
| K993205 | Booker Box, Model Pad 5010LDD · Traditional | 07/20/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | 09/15/1999SE |
Questions and answers
When was Arc Adjustable Radial Cuff Compression Device cleared by the FDA?
Arc Adjustable Radial Cuff Compression Device (K252772) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 262 days after the submission was received.
What is the product code of K252772?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.