PMA · Approved
Recalled · Class II · 2019Lamicel (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
Approved on Jun 21, 1983 through premarket approval, which rests on the device’s own clinical evidence after a 257-day review. It has been recalled 3 times.
- Decided
- Jun 21, 1983
- Review
- 257 days
- Class
- Class III
- Product code
- LOB
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P820075 has 8 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 |
| 1986 | 1 |
| 1988 | 1 |
| 1991 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 2 |
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 LOB? 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 |
|---|---|---|---|---|
| Nov 13, 2019 | Class II | Z-0733-2020 | Process control | Routine sterilization dose does not meet the required Sterility Assurance Level. |
| Nov 13, 2019 | Class II | Z-0734-2020 | Process control | Routine sterilization dose does not meet the required Sterility Assurance Level. |
| Nov 13, 2019 | Class II | Z-0735-2020 | Process control | Routine sterilization dose does not meet the required Sterility Assurance Level. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LOB devicesLOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOB
FDA has decided no LOB device since 2007.
Median 510(k) review, days · LOB
Too few LOB 510(k)s in any year since 2007 to give a median.
Recalls per year · LOB
3in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOB
2in 2013
MAUDE reports naming product code LOB, 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 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 3 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P820075 · printed Nov 6, 2026
Cite this page
510(k) Report. “P820075: Lamicel (TM).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P820075
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026