# K220525: RESPONDER Polysaccharide Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Starch Medical, Inc.
- Decided: Dec 4, 2023 after 649 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002550 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061079: Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules, Medtrade Products, Ltd. (2006) Summary page 4.

## Most influential descendants
- K240454: RESPONDER® Polysaccharide Hemostat (2024), 0 descendants of its own

## Indications for use
RESPONDER® Polysaccharide Hemostat Rx is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

Source page: https://510kreport.com/device/K220525
Methodology: https://510kreport.com/methodology