510(k) · Cleared
Recalled · Class II · 2014Mentor Sterile Saline Mammary Volume Sizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · MRD Mammary Sizer
Cleared on Apr 23, 2001 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 2001
- Review
- 45 days
- Class
- Class U
- Product code
- MRD
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK010709 Mentor Sterile Saline Mammary Volume SizersMentor Corp. · 2001
- Descendant · cites it directly · 6 of its ownK062421 Mentor Resterilizable Gel Breast Implant SizerMentor Corporation · 2006 · Recalled
- Descendant · 2 generations on · 4 of its ownK131853 Mentor Memoryshape Resterilizable Gel SizerMentor Worldwide, LLC · 2013
- Descendant · 3 generations on · 3 of its ownK151055 Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK241552 MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC · 2024
- Descendant · 4 generations on · 1 of its ownK183163 Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva…Motiva USA, LLC · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062421Mentor Resterilizable Gel Breast Implant SizerMentor Corporation · 2006 · cites it directly6descendants
- K131853Mentor Memoryshape Resterilizable Gel SizerMentor Worldwide, LLC · 2013 · 2 generations on4descendants
- K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC · 2015 · 3 generations on3descendants
- K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC · 2024 · 2 generations on1descendant
- K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010709 | Mentor Sterile Saline Mammary Volume Sizers | Mentor Corp. | 2001 | — |
| +1 | K062421 | Mentor Resterilizable Gel Breast Implant Sizer | Mentor Corporation | 2006 | 1 |
| +2 | K131853 | Mentor Memoryshape Resterilizable Gel Sizer | Mentor Worldwide, LLC | 2013 | — |
| +3 | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | Mentor Worldwide, LLC | 2015 | — |
| +2 | K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | Mentor Worldwide, LLC | 2024 | — |
| +4 | K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | Motiva USA, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062421 | Mentor Resterilizable Gel Breast Implant Sizer | 2006 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2014 | Class II | Z-2591-2014 | Error in labeling | The device labeling is stamped with 330cc and the device is actually 380cc device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062421 (Mentor Corporation, 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MRD devicesMRD Mammary Sizer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010709: Mentor Sterile Saline Mammary Volume Sizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010709
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026