# K122405: Air-Band Radial Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp., Cardiac Assist Division
- Decided: Nov 9, 2012 after 94 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: 1 generation back to K062569 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070423: TR Band, Terumo Medical Corp. (2007) Summary page 1.
- K062569: Safeguard 24 CM Pressure Assisted Dressing, Datascope Corp. (2007) Summary page 1.

## Most influential descendants
- K132293: Syvek Radial Band (2014), 0 descendants of its own
- K131411: Coseal (2013), 0 descendants of its own

## Indications for use
The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Source page: https://510kreport.com/device/K122405
Methodology: https://510kreport.com/methodology