PMA · Approved
Recalled · Class I · 2019Natrelle Highly Cohesive Silicone-Filled Breast Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan · FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Approved on Feb 20, 2013 through premarket approval, which rests on the device’s own clinical evidence after a 2,998-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Feb 20, 2013
- Review
- 2,998 days
- Class
- Class III
- Product code
- FTR
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040046 has 29 supplements since 2013: 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 |
|---|---|
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 4 |
| 2016 | 5 |
| 2017 | 7 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2019 | Class I | Z-2452-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FTR devicesFTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FTR
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTR
Too few FTR 510(k)s in any year since 2007 to give a median.
Recalls per year · FTR
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTR
30,958in 2025
MAUDE reports naming product code FTR, 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 | 5 | — | 0 | 94 |
| 2008 | 7 | — | 0 | 106 |
| 2009 | 4 | — | 0 | 53 |
| 2010 | 2 | — | 0 | 59 |
| 2011 | 2 | — | 0 | 101 |
| 2012 | 7 | — | 0 | 102 |
| 2013 | 12 | — | 0 | 120 |
| 2014 | 19 | — | 0 | 140 |
| 2015 | 28 | — | 0 | 204 |
| 2016 | 20 | — | 0 | 290 |
| 2017 | 33 | — | 0 | 930 |
| 2018 | 11 | — | 0 | 2,644 |
| 2019 | 14 | — | 2 | 21,411 |
| 2020 | 10 | — | 0 | 24,298 |
| 2021 | 21 | — | 0 | 23,365 |
| 2022 | 8 | — | 0 | 30,817 |
| 2023 | 10 | — | 0 | 29,098 |
| 2024 | 20 | — | 0 | 30,287 |
| 2025 | 16 | — | 0 | 30,958 |
| 2026 | 15 | — | 0 | — |
https://510kreport.com/device/P040046 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040046: Natrelle Highly Cohesive Silicone-Filled Breast Implants.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040046
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026