510(k) · Cleared
Recalled · Class II · 2019Cui Mammary Prothesis Sizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cox-Uphuff Intl. · MRD Mammary Sizer
Cleared on Aug 12, 1983 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 12, 1983
- Review
- 88 days
- Class
- Class U
- Product code
- MRD
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK831566 Cui Mammary Prothesis SizerCox-Uphuff Intl. · 1983
- Descendant · cites it directly · 0 of its ownK203229 NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan · 2021
Most influential descendants
Showing 1 of 1 · See all- K203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831566 | Cui Mammary Prothesis Sizer | Cox-Uphuff Intl. | 1983 | — |
| +1 | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Allergan | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2019 | Class III | Z-0702-2020 | Error in labeling | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D… |
| Jun 8, 2015 | Class II | Z-1988-2015 | Error in labeling | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K203229 (Allergan, 2021) has gone furthest, with 0 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/K831566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K831566: Cui Mammary Prothesis Sizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831566
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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