PMA · Approved
Recalled · Class II · 2019Puregraft Serene Breast Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bimini Health Tech · FWM Prosthesis, Breast, Inflatable, Internal, Saline
Approved on Nov 14, 2014 through premarket approval, which rests on the device’s own clinical evidence after an 872-day review. It has been recalled once.
- Decided
- Nov 14, 2014
- Review
- 872 days
- Class
- Class III
- Product code
- FWM
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P120011 has 26 supplements since 2015: 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 |
|---|---|
| 2015 | 1 |
| 2016 | 6 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 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 FWM? 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 18, 2019 | Class II | Z-2219-2019 | Process control | The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FWM devicesFWM Prosthesis, Breast, Inflatable, Internal, Saline: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FWM
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FWM
Too few FWM 510(k)s in any year since 2007 to give a median.
Recalls per year · FWM
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWM
8,724in 2025
MAUDE reports naming product code FWM, 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 | 3 | — | 0 | 307 |
| 2008 | 3 | — | 0 | 268 |
| 2009 | 3 | — | 0 | 123 |
| 2010 | 0 | — | 0 | 126 |
| 2011 | 0 | — | 0 | 99 |
| 2012 | 1 | — | 0 | 142 |
| 2013 | 7 | — | 0 | 105 |
| 2014 | 11 | — | 0 | 81 |
| 2015 | 6 | — | 0 | 110 |
| 2016 | 12 | — | 0 | 164 |
| 2017 | 14 | — | 0 | 4,487 |
| 2018 | 6 | — | 0 | 13,223 |
| 2019 | 5 | — | 1 | 15,465 |
| 2020 | 7 | — | 0 | 14,022 |
| 2021 | 9 | — | 1 | 11,350 |
| 2022 | 4 | — | 0 | 13,641 |
| 2023 | 6 | — | 0 | 10,640 |
| 2024 | 7 | — | 0 | 9,450 |
| 2025 | 6 | — | 0 | 8,724 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P120011 · printed Nov 4, 2026
Cite this page
510(k) Report. “P120011: Puregraft Serene Breast Implant.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P120011
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026