# K252772: Arc Adjustable Radial Cuff Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: May 22, 2026 after 262 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070423 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173563: Arc Adjustable Radial Cuff Compression Device, Tz Medical, Inc. (2018) Summary page 5.

## Indications for use
When applied by a trained health care professional, the TZ Medical ARC™ device is designed to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).

Source page: https://510kreport.com/device/K252772
Methodology: https://510kreport.com/methodology