De Novo · Granted
GrantedXSTAT
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
Granted on Apr 3, 2014 as a new device type through De Novo after a 428-day review. 6 later devices descend from it.
- Decided
- Apr 3, 2014
- Review
- 428 days
- Class
- Class II
- Product code
- PGZ
- Recalls
- None
6 later devices descend from it, 1 citing it directly.
- This deviceDEN130016 XSTATRevmedx, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK152624 Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK161020 XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK170334 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK180051 XSTAT 30, 1-PackRevmedx, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK210676 XSTAT 30 PouchRevmedx, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152624Xstat 30, 3-Pack, Xstat 30, 1-PackRevmedx, Inc. · 2015 · cites it directly5descendants
- K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. · 2016 · 2 generations on4descendants
- K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. · 2017 · 2 generations on3descendants
- K180051XSTAT 30, 1-PackRevmedx, Inc. · 2018 · 3 generations on2descendants
- K210676XSTAT 30 PouchRevmedx, Inc. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130016 | XSTAT | Revmedx, Inc. | 2014 | — |
| +1 | K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | Revmedx, Inc. | 2015 | — |
| +2 | 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 | — |
| +3 | K180051 | XSTAT 30, 1-Pack | Revmedx, Inc. | 2018 | — |
| +4 | K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | 2015 | 5 |
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?
- Of its descendants, K152624 (Revmedx, Inc., 2015) has gone furthest, with 5 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. 2014, 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 | — |
https://510kreport.com/device/DEN130016 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130016: XSTAT.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130016
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026