# K213531: TR BAND Radial Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Dec 20, 2021 after 45 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: 2 generations back to K070423 (2007). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152525: TR BAND Radial Compression Device, Terumo Medical Corporation (2015) Summary page 6.

## Most influential descendants
- K253070: Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (2025), 0 descendants of its own

## Indications for use
The TR Band® is a compression device indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

Source page: https://510kreport.com/device/K213531
Methodology: https://510kreport.com/methodology