# K191827: Sunmed Disposable Angio-Closure Pads

- Pathway: 510(k) (Traditional)
- Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
- Decided: Mar 16, 2020 after 252 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062569: Safeguard 24 CM Pressure Assisted Dressing, Datascope Corp. (2007) Summary page 4.

## Indications for use
The Sunmed disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.

Source page: https://510kreport.com/device/K191827
Methodology: https://510kreport.com/methodology