510(k) · Cleared
ClearedMENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use 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 Jan 13, 2025 as substantially equivalent to K131853 (Mentor Worldwide, LLC, 2013) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 13, 2025
- Review
- 89 days
- Class
- Class U
- Product code
- MRD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010709 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010709 Mentor Sterile Saline Mammary Volume SizersMentor Corp. · 2001 · Recalled
- 3 generations backK062421 Mentor Resterilizable Gel Breast Implant SizerMentor Corporation · 2006 · Recalled
- 2 generations backK131853 Mentor Memoryshape Resterilizable Gel SizerMentor Worldwide, LLC · 2013
- 1 generation backK151055 Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC · 2015
- This deviceK243271 MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer…Mentor Worldwide, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010709 | Mentor Sterile Saline Mammary Volume Sizers | Mentor Corp. | 2001 | 1 |
| −3 | K062421 | Mentor Resterilizable Gel Breast Implant Sizer | Mentor Corporation | 2006 | 1 |
| −2 | K131853 | Mentor Memoryshape Resterilizable Gel Sizer | Mentor Worldwide, LLC | 2013 | — |
| −1 | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | Mentor Worldwide, LLC | 2015 | — |
| 0 (this device) | K243271 | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™… | Mentor Worldwide, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K131853 | Mentor Memoryshape Resterilizable Gel SizerSummary page 5…ate Prepared: January 8, 2025 Device Name and Classification Trade Name MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer (K131853) MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer (K151055) MENTOR™ M… | 2013 |
| * | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILESummary page 5…MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer (K131853) MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer (K151055) MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552) Common Name Volume Sizer for Bre… | 2015 |
| * | K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel SizerSummary page 5…) MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer (K151055) MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552) Common Name Volume Sizer for Breast Implants Product Code MRD Device Unclassified, Pr… | 2024 |
| † | P990075 | Mentor Corporation Saline-Filled and Spectrum (R) Mammary Prostheses | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K131853.
How does its category compare?
All MRD devicesMRD Mammary Sizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243271: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243271
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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