510(k) · Cleared
ClearedPuraStat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3-D Matrix, Inc. · QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Cleared on Feb 28, 2023 as substantially equivalent to K210098 (3-D Matrix, Inc., 2021) after a 195-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Feb 28, 2023
- Review
- 195 days
- Class
- Class II
- Product code
- QAU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170015 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN170015 Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. · 2018
- 1 generation backK210098 PuraStat-GI3-D Matrix, Inc. · 2021
- This deviceK222481 PuraStat3-D Matrix, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK242250 PuraStat3-D Matrix Europe SAS · 2024
- Descendant · 2 generations on · 1 of its ownK253924 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · 2 generations on · 0 of its ownK261503 PuraStat GI3-D Matrix, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −2 | DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018 | — |
| −1 | K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021 | — |
| 0 (this device) | K222481 | PuraStat | 3-D Matrix, Inc. | 2023 | — |
| +1 | K242250 | PuraStat | 3-D Matrix Europe SAS | 2024 | — |
| +2 | K253924 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +2 | K261503 | PuraStat GI | 3-D Matrix, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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 QAU? 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 QAU device
- #1 K242250 PuraStatscore 14.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K210098 | PuraStat-GISummary page 4…: 21 CFR 878.4456 Regulatory Class: II Product Code: QAU Panel: General & Plastic Surgery 3. PREDICATE DEVICE Predicate Device: 3-D Matrix, Inc.’s PuraStat-GI (K210098) 4. DEVICE DESCRIPTION PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is… | 2021 |
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 |
|---|---|---|---|
| K242250 | PuraStat | 2024 | 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 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K242250 (3-D Matrix Europe SAS, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QAU devicesQAU Hemostatic Device For Endoscopic Gastrointestinal Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QAU
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QAU
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAU
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAU
121in 2025
MAUDE reports naming product code QAU, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 218 |
| 2020 | 1 | — | 0 | 73 |
| 2021 | 2 | — | 0 | 112 |
| 2022 | 1 | — | 0 | 135 |
| 2023 | 1 | — | 0 | 132 |
| 2024 | 3 | 211 | 2 | 154 |
| 2025 | 0 | — | 0 | 121 |
| 2026 | 3 | 89 | 1 | — |
What is it indicated for?
PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222481: PuraStat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222481
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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