# K210676: XSTAT 30 Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Revmedx, Inc.
- Decided: Aug 27, 2021 after 175 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: 5 generations back to DEN130016 (2014). 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)
- K180051: XSTAT 30, 1-Pack, Revmedx, Inc. (2018) Summary page 4.

## Most influential descendants
- K253290: Xstat P15 (2025), 0 descendants of its own

## Indications for use
XSTAT 30 Pouch 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 30 Pouch 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 30 Pouch 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 30 Pouch 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/K210676
Methodology: https://510kreport.com/methodology