510(k) · Cleared
ClearedEdwards MC3 Tricuspid annuloplasty ring (4900)
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 23, 2025 as substantially equivalent to K020864 (Edwards Lifesciences, LLC, 2002) after an 88-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Sep 23, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923367 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK923367 Cosgrove Edwards Annuloplasty System, Model 4600Baxter Healthcare Corp · 1993
- 1 generation backK020864 Edwards MC Tricuspid Annuloplasty System, Model 4900Edwards Lifesciences, LLC · 2002
- This deviceK251982 Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923367 | Cosgrove Edwards Annuloplasty System, Model 4600 | Baxter Healthcare Corp | 1993 | — |
| −1 | K020864 | Edwards MC Tricuspid Annuloplasty System, Model 4900 | Edwards Lifesciences, LLC | 2002 | — |
| 0 (this device) | K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | 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 |
|---|---|---|---|
| * | K020864 | Edwards MC Tricuspid Annuloplasty System, Model 4900Summary page 5…21 CFR Part 870.3800, Product Code KRH, Class II (Special Controls) Predicate Device: K020864 Edwards MC3 Tricuspid annuloplasty ring, Model 4900 Device Description: The Ed… | 2002 |
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 32 years and passes through 2 companies; a new generation was cleared every 23.4 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K020864.
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 Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251982: Edwards MC3 Tricuspid annuloplasty ring (4900).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251982
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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