FDA product code · General and plastic surgery
Absorbable Collagen Hemostatic Agent With Thrombin
4 FDA decisions since 1999. 1 recall names this code; it is not Class I.
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PMX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PMX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMX
Too few PMX 510(k)s in any year since 2007 to give a median.
Recalls per year · PMX
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMX
5in 2025
MAUDE reports naming product code PMX, 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 | 2 | — | 0 | 0 |
| 2017 | 8 | — | 0 | 0 |
| 2018 | 11 | — | 0 | 1 |
| 2019 | 16 | — | 0 | 2 |
| 2020 | 10 | — | 0 | 1 |
| 2021 | 5 | — | 0 | 2 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 5 |
| 2024 | 3 | — | 0 | 5 |
| 2025 | 4 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
Planning a device in PMX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 878.4490.