PMA · Approved
Recalled · Class II · 2024Seprafilm (TM) (Hal-F (TM)) Bioresorbable Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · MCN Barrier, Absorbable, Adhesion
Approved on Aug 12, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 290-day review. It has been recalled 5 times.
- Decided
- Aug 12, 1996
- Review
- 290 days
- Class
- Class III
- Product code
- MCN
- Recalls
- 5
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P950034 has 52 supplements since 1996: 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 |
|---|---|
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 4 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 5 |
| 2011 | 2 |
| 2012 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
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 MCN? 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 15, 2024 | Class II | Z-1689-2024 | Under Investigation by firm | Product was distributed in the United States without proper regulatory approval. |
| Jun 13, 2012 | Class II | Z-1856-2012 | Packaging process control | Sterility of product may be compromised due to packaging defect |
| Jun 13, 2012 | Class II | Z-1855-2012 | Packaging process control | Sterility of product may be compromised due to packaging defect |
| Apr 10, 2008 | Not classified | Z-1648-2008 | Employee error | Sterility may be compromised |
| Apr 10, 2008 | Not classified | Z-1647-2008 | Employee error | Sterility may be compromised |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MCN devicesMCN Barrier, Absorbable, Adhesion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCN
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCN
Too few MCN 510(k)s in any year since 2007 to give a median.
Recalls per year · MCN
No recall names MCN since 2007.
Adverse event reports per year · MCN
38in 2025
MAUDE reports naming product code MCN, 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 | 1 | — | 0 | 32 |
| 2008 | 3 | — | 0 | 61 |
| 2009 | 2 | — | 0 | 73 |
| 2010 | 5 | — | 0 | 42 |
| 2011 | 8 | — | 0 | 68 |
| 2012 | 4 | — | 0 | 48 |
| 2013 | 3 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 53 |
| 2015 | 2 | — | 0 | 68 |
| 2016 | 7 | — | 0 | 71 |
| 2017 | 5 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 65 |
| 2019 | 7 | — | 0 | 55 |
| 2020 | 7 | — | 0 | 44 |
| 2021 | 8 | — | 0 | 42 |
| 2022 | 7 | — | 0 | 53 |
| 2023 | 4 | — | 0 | 45 |
| 2024 | 9 | — | 0 | 38 |
| 2025 | 6 | — | 0 | 38 |
| 2026 | 6 | — | 0 | — |
https://510kreport.com/device/P950034 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950034: Seprafilm (TM) (Hal-F (TM)) Bioresorbable Membrane.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950034
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026