# K253290: Xstat P15

- Pathway: 510(k) (Traditional)
- Applicant: Revmedx, Inc.
- Decided: Nov 12, 2025 after 44 days
- Product code: PGZ (Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use)
- Device class: 2
- Regulation: 21 CFR 878.4452
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN130016 (2014). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210676: XSTAT 30 Pouch, Revmedx, Inc. (2021) Summary page 5.

## Indications for use
XSTAT P15 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT P15 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents. XSTAT P15 is a temporary device for use up to six (6) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT P15 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

Source page: https://510kreport.com/device/K253290
Methodology: https://510kreport.com/methodology