# K210751: S.E.A.L. Hemostatic Wound Spray

- Pathway: 510(k) (Traditional)
- Applicant: Bc3 Technologies, Inc.
- Decided: Feb 2, 2023 after 692 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 K953781 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.
- K010933: Seal-on Topical Hempstatic Powder Spray, Alltracel Pharma, Ltd. (2002) Summary page 4.

## Indications for use
S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.

Source page: https://510kreport.com/device/K210751
Methodology: https://510kreport.com/methodology