PMA · Approved
Recalled · 2011Apligraf (Graftskin)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organogenesis, Inc. · MGR Dressing, Wound And Burn, Interactive
Approved on May 22, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 961-day review. It has been recalled 6 times.
- Decided
- May 22, 1998
- Review
- 961 days
- Class
- Class III
- Product code
- MGR
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P950032 has 66 supplements since 1998: 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 |
|---|---|
| 1998 | 1 |
| 1999 | 8 |
| 2000 | 5 |
| 2001 | 8 |
| 2002 | 6 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 4 |
| 2009 | 6 |
| 2010 | 5 |
| 2011 | 7 |
| 2012 | 3 |
| 2013 | 4 |
| 2014 | 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 MGR? 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 |
|---|---|---|---|---|
| Feb 21, 2011 | Not classified | Z-1747-2011 | Packaging process control | Product sterility may be compromised |
| Jan 30, 2011 | Not classified | Z-1746-2011 | Material/Component Contamination | Product sterility compromised |
| Aug 2, 2010 | Not classified | Z-2589-2010 | Process control | Product is contaminated with a yeast identified as Pseudozyma antarctica. |
| Sep 27, 2009 | Not classified | Z-0181-2010 | Packaging process control | Unit contaminated with Staphylococcus epidermidis |
| Dec 26, 2007 | Not classified | Z-0675-2008 | Material/Component Contamination | Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism. |
| Sep 29, 2006 | Not classified | Z-0068-2007 | Other | Product pH out of specification |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MGR devicesMGR Dressing, Wound And Burn, Interactive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MGR
Too few MGR 510(k)s in any year since 2007 to give a median.
Recalls per year · MGR
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGR
1in 2020
MAUDE reports naming product code MGR, 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 | — | 1 | 2 |
| 2008 | 5 | — | 0 | 29 |
| 2009 | 6 | — | 1 | 6 |
| 2010 | 7 | — | 1 | 3 |
| 2011 | 9 | — | 2 | 11 |
| 2012 | 9 | — | 0 | 23 |
| 2013 | 8 | — | 0 | 18 |
| 2014 | 1 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 3 | — | 0 | 3 |
| 2017 | 7 | — | 0 | 0 |
| 2018 | 9 | — | 0 | 0 |
| 2019 | 12 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 1 |
| 2021 | 6 | — | 0 | 0 |
| 2022 | 6 | — | 0 | 0 |
| 2023 | 7 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P950032 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950032: Apligraf (Graftskin).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950032
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026