510(k) · Cleared
ClearedMentor Memoryshape Resterilizable Gel Sizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Worldwide, LLC · MRD Mammary Sizer
Cleared on Jul 17, 2013 as substantially equivalent to K062421 (Mentor Corporation, 2006) after a 26-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 17, 2013
- Review
- 26 days
- Class
- Class U
- Product code
- MRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010709 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010709 Mentor Sterile Saline Mammary Volume SizersMentor Corp. · 2001 · Recalled
- 1 generation backK062421 Mentor Resterilizable Gel Breast Implant SizerMentor Corporation · 2006 · Recalled
- This deviceK131853 Mentor Memoryshape Resterilizable Gel SizerMentor Worldwide, LLC · 2013
- Descendant · cites it directly · 3 of its ownK151055 Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK183163 Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva…Motiva USA, LLC · 2019
- Descendant · cites it directly · 0 of its ownK243271 MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer…Mentor Worldwide, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK200706 Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC · 2015 · cites it directly3descendants
- K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC · 2019 · 2 generations on1descendant
- K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™…Mentor Worldwide, LLC · 2025 · cites it directly0descendants
- K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010709 | Mentor Sterile Saline Mammary Volume Sizers | Mentor Corp. | 2001 | 1 |
| −1 | K062421 | Mentor Resterilizable Gel Breast Implant Sizer | Mentor Corporation | 2006 | 1 |
| 0 (this device) | K131853 | Mentor Memoryshape Resterilizable Gel Sizer | Mentor Worldwide, LLC | 2013 | — |
| +1 | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | Mentor Worldwide, LLC | 2015 | — |
| +2 | K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | Motiva USA, LLC | 2019 | — |
| +1 | K243271 | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™… | Mentor Worldwide, LLC | 2025 | — |
| +3 | K200706 | Sientra OPUS Silicone Gel Breast Implant Sizer | Sientra, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRD device
- #1 K241552 MENTOR™ MemoryGel™ Enhance Single Use Gel Sizerscore 11.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062421 | Mentor Resterilizable Gel Breast Implant SizerSummary page 1…Unclassified, Pre-Amendment Panel: General & Plastic Surgery Product Code: MRD Predicate Device: K06242 1, Mentor Resterilizable Gel Breast Implant Sizer Indication for Use: The Mentor Resterilizable MvemoryShape Gel Sizer is indicate… | 2006 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K151055 (Mentor Worldwide, LLC, 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K062421.
How does its category compare?
All MRD devicesMRD Mammary Sizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MRD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRD
Too few MRD 510(k)s in any year since 2007 to give a median.
Recalls per year · MRD
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRD
48in 2025
MAUDE reports naming product code MRD, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 6 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 24 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 1 | — | 1 | 14 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 1 | — | 0 | 48 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mentor Resterilizable MemoryShape m Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape m breast implant to be implanted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131853: Mentor Memoryshape Resterilizable Gel Sizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131853
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026