510(k) · Cleared
ClearedXSTAT 30 Pouch
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 Aug 27, 2021 as substantially equivalent to K180051 (Revmedx, Inc., 2018) after a 175-day review. Its family tree reaches back 5 generations to 2014. 1 later device descends from it.
- Decided
- Aug 27, 2021
- Review
- 175 days
- Class
- Class II
- Product code
- PGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN130016 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN130016 XSTATRevmedx, Inc. · 2014
- 4 generations backK152624 Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015
- 3 generations backK161020 XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016
- 2 generations backK170334 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017
- 1 generation backK180051 XSTAT 30, 1-PackRevmedx, Inc. · 2018
- This deviceK210676 XSTAT 30 PouchRevmedx, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253290 Xstat P15Revmedx, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253290Xstat P15Revmedx, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN130016 | XSTAT | Revmedx, Inc. | 2014 | — |
| −4 | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | Revmedx, Inc. | 2015 | — |
| −3 | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Revmedx, Inc. | 2016 | — |
| −2 | K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | Revmedx, Inc. | 2017 | — |
| −1 | K180051 | XSTAT 30, 1-Pack | Revmedx, Inc. | 2018 | — |
| 0 (this device) | K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021 | — |
| +1 | K253290 | Xstat P15 | Revmedx, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K180051 | XSTAT 30, 1-PackSummary page 4…n-absorbable, Gauze/Sponge for external use Product Classification & Code: Class II 21 CFR 878.4452, PGZ NAB Predicate Devices: XSTAT 30 Gen2 (K180051) Reference Clearances: XSTAT 30 (DEN13006/K130218/K152624/K170334) and XSTAT 12 (K161020/K170334) Intended Use / Indications fo… | 2018 |
| † | K130218 | XSTAT 30 | |
| † | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | 2015 |
| † | K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | 2017 |
| † | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253290 | Xstat P15 | 2025 | 0 |
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 7 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K253290 (Revmedx, Inc., 2025) has gone furthest, with 0 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. 2021, 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 Pouch 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 30 Pouch 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 Pouch is a temporary device for use up to six (6) hours until surgical…
Read the full statement (161 words)
XSTAT 30 Pouch 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 30 Pouch 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 Pouch 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 30 Pouch 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/K210676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210676: XSTAT 30 Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210676
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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