# K253017: BloodSTOP iX Trauma Matrix (TM-iX-20)

- Pathway: 510(k) (Traditional)
- Applicant: Lifescience Plus, Inc.
- Decided: Apr 30, 2026 after 223 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: 7 generations back to K002550 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123387: Quikclot Hemostatic Dressing, Z-Medica, LLC (2013) Summary page 5.

## Indications for use
BloodSTOP iX Trauma Matrix is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for external temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Source page: https://510kreport.com/device/K253017
Methodology: https://510kreport.com/methodology