# K170334: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack

- Pathway: 510(k) (Traditional)
- Applicant: Revmedx, Inc.
- Decided: May 1, 2017 after 88 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: 3 generations back to DEN130016 (2014). 3 ancestors in all.
3 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 5.
- K161020: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack, Revmedx, Inc. (2016) Summary page 5.

## Most influential descendants
- 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 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 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 from immediate life-threatening 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 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. 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 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 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 from immediate life-threatening 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 12 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/K170334
Methodology: https://510kreport.com/methodology