510(k) · Cleared
ClearedCarpentier-Edwards Physio Tricuspid Annuloplasty Ring
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 Jun 24, 2011 as substantially equivalent to K020864 (Edwards Lifesciences, LLC, 2002) and 2 other predicates after a 206-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Jun 24, 2011
- Review
- 206 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923367 (1993). 3 ancestors in all, the oldest K912554 (1991). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK103520 Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC · 2011
- Descendant · cites it directly · 1 of its ownK163608 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic…Biostable Science & Engineering, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK260498 TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l. · 2026
- Descendant · 2 generations on · 0 of its ownK171431 HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic…Biostable Science & Engineering, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc. · 2017 · cites it directly1descendant
- K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l. · 2026 · cites it directly0descendants
- K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc. · 2017 · 2 generations on0descendants
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) | K103520 | Carpentier-Edwards Physio Tricuspid Annuloplasty Ring | Edwards Lifesciences, LLC | 2011 | — |
| +1 | K163608 | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty… | Biostable Science & Engineering, Inc. | 2017 | — |
| +1 | K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | 2026 | — |
| +2 | K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty… | Biostable Science & Engineering, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2026 | 1 | 0 |
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? (3)
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 1…model 6200 Classification Name: Class 11,CFR 870.3800 Annuloplasty Ring, KRH Predicate Device(s): Edwards MC30 Tricuspid annuloplasty ring (K(020864) Cosgrove-Edwardse annuloplasty system (K923367) Carpentier-Edw… | 2002 |
| * | K923367 | Cosgrove Edwards Annuloplasty System, Model 4600Summary page 1…y Ring, KRH Predicate Device(s): Edwards MC30 Tricuspid annuloplasty ring (K(020864) Cosgrove-Edwardse annuloplasty system (K923367) Carpentier-Edwards t Classic0 Tricuspid annuloplasty ring (K91 2554) Device Description:… | 1993 |
| * | K912554 | Annuloplasty Rings, Model 4400 Mirtal and 4500 TriSummary page 1…Cosgrove-Edwardse annuloplasty system (K923367) Carpentier-Edwards t Classic0 Tricuspid annuloplasty ring (K91 2554) Device Description: The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model… | 1991 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K163608 (Biostable Science & Engineering, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 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. 2011, 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 Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended 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/K103520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103520
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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