510(k) · Cleared
ClearedNATRELLE INSPIRA Single Use Sizers for Gel Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jun 2, 2021 as substantially equivalent to K831566 (Cox-Uphuff Intl., 1983) after a 212-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jun 2, 2021
- Review
- 212 days
- Class
- Class U
- Product code
- MRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831566 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK831566 Cui Mammary Prothesis SizerCox-Uphuff Intl. · 1983 · Recalled
- This deviceK203229 NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831566 | Cui Mammary Prothesis Sizer | Cox-Uphuff Intl. | 1983 | 2 |
| 0 (this device) | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Allergan | 2021 | — |
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 |
|---|---|---|---|
| * | K831566 | Cui Mammary Prothesis SizerSummary page 4…Classification Regulation: Unclassified, Pre- Amendment Product Code: MRD Predicate Device: Natrelle® Re-Sterilizable Breast Implant Sizers (K831566) Reference Device: Natrelle® 133S Tissue Expander (K182054) Device Description: NATRELLE INSPIRA® Single Us… | 1983 |
| † | K182054 | Natrelle 133S Tissue Expander | 2018 |
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?
- Its one ancestor has a recall.
How does its category compare?
All MRD devicesMRD Mammary Sizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203229: NATRELLE INSPIRA Single Use Sizers for Gel Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203229
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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