PMA · Approved
Recalled · Class II · 2013Instat (TM) Collagen Absorbable Hemostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · LMF Agent, Absorbable Hemostatic, Collagen Based
Approved on Oct 10, 1985 through premarket approval, which rests on the device’s own clinical evidence after a 657-day review. It has been recalled 2 times.
- Decided
- Oct 10, 1985
- Review
- 657 days
- Class
- Class III
- Product code
- LMF
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P830079 has 14 supplements since 1985: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1995 | 1 |
| 1999 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1289-2013 | Process control | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| Mar 28, 2013 | Class II | Z-1288-2013 | Process control | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LMF devicesLMF Agent, Absorbable Hemostatic, Collagen Based: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMF
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LMF
Too few LMF 510(k)s in any year since 2007 to give a median.
Recalls per year · LMF
2in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LMF
93in 2025
MAUDE reports naming product code LMF, 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 | 22 | — | 0 | 15 |
| 2008 | 11 | — | 1 | 55 |
| 2009 | 11 | — | 0 | 63 |
| 2010 | 14 | — | 0 | 76 |
| 2011 | 11 | — | 0 | 85 |
| 2012 | 14 | — | 16 (2) | 51 |
| 2013 | 33 | — | 0 | 62 |
| 2014 | 37 | — | 0 | 93 |
| 2015 | 22 | — | 0 | 94 |
| 2016 | 15 | — | 0 | 85 |
| 2017 | 12 | — | 0 | 121 |
| 2018 | 16 | — | 0 | 109 |
| 2019 | 23 | — | 0 | 151 |
| 2020 | 15 | — | 0 | 146 |
| 2021 | 27 | — | 0 | 96 |
| 2022 | 16 | — | 0 | 58 |
| 2023 | 20 | — | 2 | 271 |
| 2024 | 18 | — | 0 | 134 |
| 2025 | 16 | — | 0 | 93 |
| 2026 | 15 | — | 1 | — |
https://510kreport.com/device/P830079 · printed Nov 4, 2026
Cite this page
510(k) Report. “P830079: Instat (TM) Collagen Absorbable Hemostat.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P830079
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026