510(k) · Cleared
ClearedXstat P15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revmedx, Inc. · PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Cleared on Nov 12, 2025 as substantially equivalent to K210676 (Revmedx, Inc., 2021) after a 44-day review. Its family tree reaches back 6 generations to 2014.
- Decided
- Nov 12, 2025
- Review
- 44 days
- Class
- Class II
- Product code
- PGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN130016 (2014). No later device cites it as a predicate yet.
- Root · 6 generations backDEN130016 XSTATRevmedx, Inc. · 2014
- 5 generations backK152624 Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015
- 4 generations backK161020 XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016
- 3 generations backK170334 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017
- 2 generations backK180051 XSTAT 30, 1-PackRevmedx, Inc. · 2018
- 1 generation backK210676 XSTAT 30 PouchRevmedx, Inc. · 2021
- This deviceK253290 Xstat P15Revmedx, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN130016 | XSTAT | Revmedx, Inc. | 2014 | — |
| −5 | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | Revmedx, Inc. | 2015 | — |
| −4 | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Revmedx, Inc. | 2016 | — |
| −3 | K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | Revmedx, Inc. | 2017 | — |
| −2 | K180051 | XSTAT 30, 1-Pack | Revmedx, Inc. | 2018 | — |
| −1 | K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021 | — |
| 0 (this device) | K253290 | Xstat P15 | Revmedx, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGZ device
- #1 K210676 XSTAT 30 Pouchscore 6.1 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210676 | XSTAT 30 PouchSummary page 5…Expandable, Hemostatic Sponge for Temporary Internal Use Product Classification & Code: Class II 21 CFR 878.4452, PGZ Predicate Devices: XSTAT P30 (K210676) Intended Use / Indications for Use: Intended Use: XSTAT P15 is intended to be a hemostatic wound dressing. Indications for U… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All PGZ devicesPGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGZ
Too few PGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PGZ
No recall names PGZ since 2007.
Adverse event reports per year · PGZ
No MAUDE report names PGZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (157 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253290 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253290: Xstat P15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253290
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026