# K111837: Radial Artery Compression Tourniquet

- Pathway: 510(k) (Traditional)
- Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
- Decided: Sep 27, 2011 after 90 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: 4 generations back to K984177 (1998). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 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.
- K092503: Radar Vascular Compression Devices, Advanced Vascular Dynamics (2009) Summary page 1.

## Most influential descendants
- K142359: Vasc Band hemostat (2014), 3 descendants of its own
- K162988: PreludeSYNC Radial Compression Device (2017), 1 descendant of its own
- K262086: PreludeSYNC™ Radial Compression Device (2026), 0 descendants of its own
- K170958: ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm (2017), 0 descendants of its own

## Indications for use
The Radial Artery Compression Tourniquet is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Source page: https://510kreport.com/device/K111837
Methodology: https://510kreport.com/methodology