# K152624: Xstat 30, 3-Pack, Xstat 30, 1-Pack

- Pathway: 510(k) (Traditional)
- Applicant: Revmedx, Inc.
- Decided: Dec 7, 2015 after 84 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: 1 generation back to DEN130016 (2014). 1 ancestor in all.
5 later devices descend from it; 2 cite 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)
- DEN130016: XSTAT, Revmedx, Inc. (2014) Summary page 4.
- DEN130016: XSTAT, Revmedx, Inc. (2014). Our reading of the summary gave K130218, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130016, XSTAT (Revmedx, Inc.), granted Apr 3, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.

## Most influential descendants
- K161020: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (2016), 4 descendants of its own
- 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 30 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 30 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, 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 30 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/K152624
Methodology: https://510kreport.com/methodology