# K161020: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

- Pathway: 510(k) (Traditional)
- Applicant: Revmedx, Inc.
- Decided: Jul 28, 2016 after 107 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: 2 generations back to DEN130016 (2014). 2 ancestors in all.
4 later devices descend 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)
- K152624: Xstat 30, 3-Pack, Xstat 30, 1-Pack, Revmedx, Inc. (2015) Summary page 4.

## Most influential descendants
- K170334: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (2017), 3 descendants of its own
- K180051: XSTAT 30, 1-Pack (2018), 2 descendants of its own
- K210676: XSTAT 30 Pouch (2021), 1 descendant of its own
- K253290: Xstat P15 (2025), 0 descendants of its own

## Indications for use
XSTAT-12 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents. XSTAT-12 is a temporary device for use up to four (4) 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, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT-12 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space, the sacral space above the inguinal ligament; or tissues above the clavicle.

Source page: https://510kreport.com/device/K161020
Methodology: https://510kreport.com/methodology