510(k) · Cleared
ClearedXSTAT-12, 3-Pack, XSTAT-12, 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 Jul 28, 2016 as substantially equivalent to K152624 (Revmedx, Inc., 2015) after a 107-day review. Its family tree reaches back 2 generations to 2014. 4 later devices descend from it.
- Decided
- Jul 28, 2016
- Review
- 107 days
- Class
- Class II
- Product code
- PGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130016 (2014). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN130016 XSTATRevmedx, Inc. · 2014
- 1 generation backK152624 Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015
- This deviceK161020 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −2 | DEN130016 | XSTAT | Revmedx, Inc. | 2014 | — |
| −1 | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | Revmedx, Inc. | 2015 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-PackSummary page 4…bable, Expandable, Hemostatic Sponge for Temporary Internal Use Product Classification & Code: 21 CFR 878.4452; PGZ, Class II Predicate Devices: XSTAT 30 (K152624) Reference Device: XSTAT (DEN130016/K130218) Intended Use / Indications for Use: Intended Use: The XSTAT-12 is intended for th… | 2015 |
| † | DEN130016 | XSTAT | 2014 |
| † | K130218 | XSTAT |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | 2017 | 3 |
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 2 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K170334 (Revmedx, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K152624.
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. 2016, 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-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 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 bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4…
Read the full statement (122 words)
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 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 bleeding from, 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-12 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/K161020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161020: XSTAT-12, 3-Pack, XSTAT-12, 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/K161020
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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