510(k) · Cleared
ClearedXSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 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 May 1, 2017 as substantially equivalent to K152624 (Revmedx, Inc., 2015) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 2014. 3 later devices descend from it.
- Decided
- May 1, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- PGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN130016 (2014). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN130016 XSTATRevmedx, Inc. · 2014
- 2 generations backK152624 Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015
- 1 generation backK161020 XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016
- This deviceK170334 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK180051 XSTAT 30, 1-PackRevmedx, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK210676 XSTAT 30 PouchRevmedx, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK253290 Xstat P15Revmedx, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130016 | XSTAT | Revmedx, Inc. | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021 | — |
| +3 | K253290 | Xstat P15 | Revmedx, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-PackSummary page 5…e: 21 CFR 878.4452; PGZ, Class II (1) 21 CFR 878.4014, NAB, Class I (2) NOTE: Product Classification is Class II Predicate Devices: XSTAT 30 (K152624) XSTAT 12 (K161020) Reference Device: XSTAT (DEN13006/K130218) Intended Use / Indications for Use: Intended Use - Devic… | 2015 |
| * | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-PackSummary page 5…PGZ, Class II (1) 21 CFR 878.4014, NAB, Class I (2) NOTE: Product Classification is Class II Predicate Devices: XSTAT 30 (K152624) XSTAT 12 (K161020) Reference Device: XSTAT (DEN13006/K130218) Intended Use / Indications for Use: Intended Use - Device #1: The XSTAT 30 is inte… | 2016 |
| † | K130218 | XSTAT |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180051 | XSTAT 30, 1-Pack | 2018 | 2 |
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 3 years and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180051 (Revmedx, Inc., 2018) has gone furthest, with 2 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. 2017, 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 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.…
Read the full statement (312 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170334: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; 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/K170334
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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