510(k) · Cleared
ClearedCarpentier-Edwards Physio Annuloplasty Ring (4450)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · KRH Ring, Annuloplasty
Cleared on Sep 17, 2025 as substantially equivalent to K926138 (Baxter Healthcare Corp, 1993) after a 107-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 17, 2025
- Review
- 107 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926138 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
- This deviceK251688 Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926138 | Carpentier-Edwards Physio Annuloplasty Ring | Baxter Healthcare Corp | 1993 | — |
| 0 (this device) | K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | 2025 | — |
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 KRH? 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 KRH device
- #1 K261707 MEMO 4D Curve™ Semirigid mitral annuloplasty…score 12.7 · 5 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 |
|---|---|---|---|
| * | K926138 | Carpentier-Edwards Physio Annuloplasty RingSummary page 5…ty Ring 21 CFR Part 870.3800, Product Code KRH, Class II (Special Controls) Predicate Device: K926138 Carpentier-Edwards Physio Annuloplasty Device Description: Ring, model 4450 The Carpen… | 1993 |
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 no recall.
- 6 other devices also cite its predicate K926138.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KRH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRH
No recall names KRH since 2007.
Adverse event reports per year · KRH
420in 2025
MAUDE reports naming product code KRH, 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 | 4 | 90 | 0 | 261 |
| 2008 | 2 | — | 0 | 1,288 |
| 2009 | 8 | 68 | 0 | 973 |
| 2010 | 2 | — | 0 | 630 |
| 2011 | 2 | — | 0 | 321 |
| 2012 | 0 | — | 0 | 90 |
| 2013 | 0 | — | 0 | 97 |
| 2014 | 1 | — | 0 | 73 |
| 2015 | 0 | — | 0 | 145 |
| 2016 | 1 | — | 0 | 347 |
| 2017 | 0 | — | 0 | 379 |
| 2018 | 2 | — | 0 | 378 |
| 2019 | 2 | — | 0 | 349 |
| 2020 | 2 | — | 0 | 340 |
| 2021 | 0 | — | 0 | 423 |
| 2022 | 0 | — | 0 | 372 |
| 2023 | 2 | — | 0 | 324 |
| 2024 | 1 | — | 0 | 407 |
| 2025 | 4 | 98 | 0 | 420 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Carpentier-Edwards Physio annuloplasty ring is intended for the correction of mitral valve insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251688: Carpentier-Edwards Physio Annuloplasty Ring (4450).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251688
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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