510(k) · Cleared
ClearedXstat 30, 3-Pack, Xstat 30, 1-Pack
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 Dec 7, 2015 as substantially equivalent to DEN130016 (Revmedx, Inc., 2014) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 2014. 5 later devices descend from it.
- Decided
- Dec 7, 2015
- Review
- 84 days
- Class
- Class II
- Product code
- PGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN130016 (2014). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130016 XSTATRevmedx, Inc. · 2014
- This deviceK152624 Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK161020 XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK170334 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK180051 XSTAT 30, 1-PackRevmedx, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK210676 XSTAT 30 PouchRevmedx, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK253290 Xstat P15Revmedx, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016 · cites it directly4descendants
- K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017 · cites it directly3descendants
- K180051XSTAT 30, 1-PackRevmedx, Inc. · 2018 · 2 generations on2descendants
- K210676XSTAT 30 PouchRevmedx, Inc. · 2021 · 3 generations on1descendant
- K253290Xstat P15Revmedx, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130016 | XSTAT | Revmedx, Inc. | 2014 | — |
| 0 (this device) | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | Revmedx, Inc. | 2015 | — |
| +1 | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Revmedx, Inc. | 2016 | — |
| +1 | 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 | — |
| +3 | K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021 | — |
| +4 | K253290 | Xstat P15 | Revmedx, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
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 K253290 Xstat P15score 11.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN130016 | XSTATSummary page 4…Non-Absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use Product Classification & Code: 21 CFR 878.4452; PGZ Predicate Devices: XSTAT (DEN130016; K130218) Intended Use / Indications for Use: Intended Use: The XSTAT 30 is intended for the control of bleeding… | 2014 |
| * | DEN130016 | XSTAT 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. | 2014 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K161020 (Revmedx, Inc., 2016) has gone furthest, with 4 descendants of its own.
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. 2015, 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 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…
Read the full statement (123 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152624: Xstat 30, 3-Pack, Xstat 30, 1-Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152624
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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