# K201695: Patent Hemostasis Band (PH Band)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Ingenuities
- Decided: Oct 30, 2020 after 130 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162027: TRAcelet Compression Device, Medtronic Vascular (2016) Summary page 5.

## Indications for use
The PH Band is a compression device used to assist hemostasis of the radial artery after a transradial procedure.

Source page: https://510kreport.com/device/K201695
Methodology: https://510kreport.com/methodology