510(k) · Cleared

Cleared

Edwards MC Tricuspid Annuloplasty System, Model 4900

K020864510(k) SpecialCleared Apr 17, 200230-day reviewClass II21 CFR 870.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edwards Lifesciences, LLC · KRH Ring, Annuloplasty

Cleared on Apr 17, 2002 as substantially equivalent to K923367 (Baxter Healthcare Corp, 1993) after a 30-day review. Its family tree reaches back 1 generation to 1993. 10 later devices descend from it.

Decided: Apr 17, 2002
Review: 30 days
Class: Class II
Product code: KRH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923367 (1993). 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK923367 Cosgrove Edwards Annuloplasty System, Model 4600Baxter Healthcare Corp · 1993
This deviceK020864 Edwards MC Tricuspid Annuloplasty System, Model 4900Edwards Lifesciences, LLC · 2002
Descendant · cites it directly · 3 of its ownK103520 Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC · 2011
Descendant · cites it directly · 3 of its ownK032250 Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC · 2003
Descendant · 2 generations on · 1 of its ownK163608 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic…Biostable Science & Engineering, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK260498 TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l. · 2026
Descendant · cites it directly · 0 of its ownK251982 Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003high 2 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K103520Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC · 2011 · cites it directly3descendants
K032250Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC · 2003 · cites it directly3descendants
K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc. · 2017 · 2 generations on1descendant
K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l. · 2026 · 2 generations on0descendants
K251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923367	Cosgrove Edwards Annuloplasty System, Model 4600	Baxter Healthcare Corp	1993	—
0 (this device)	K020864	Edwards MC Tricuspid Annuloplasty System, Model 4900	Edwards Lifesciences, LLC	2002	—
+1	K103520	Carpentier-Edwards Physio Tricuspid Annuloplasty Ring	Edwards Lifesciences, LLC	2011	—
+1	K032250	Geoform Annuloplasty Ring, Mitral Model 4200	Edwards Lifesciences, LLC	2003	—
+2	K163608	HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty…	Biostable Science & Engineering, Inc.	2017	—
+2	K260498	TriMemo™ SEMIRIGID ANNULOPLASTY RING	Corcym S.r.l.	2026	—
+1	K251982	Edwards MC3 Tricuspid annuloplasty ring (4900)	Edwards Lifesciences, LLC	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2009	2	0
2010	1	0
2011	1	0
2017	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K020864, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K923367	Cosgrove Edwards Annuloplasty System, Model 4600 Summary page 1 …atory Affairs Associate March 15, 2002 Edwards MC? Tricuspid Annulplasty System Class II, CFR 870.3800 Annuloplasty Ring, 74 KRH Cosgrove-Edwards™ Annuloplasty System (K923367) The Edwards MC? Tricuspid Annuloplasty System, Model 4900, consists of two primary components; the implantable annuloplasty rin…	Baxter Healthcare Corp	1993	—

Also cleared against K923367: 5 other devices →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103520	Carpentier-Edwards Physio Tricuspid Annuloplasty Ring	Edwards Lifesciences, LLC	2011	3
K032250	Geoform Annuloplasty Ring, Mitral Model 4200	Edwards Lifesciences, LLC	2003	3
K251982	Edwards MC3 Tricuspid annuloplasty ring (4900)	Edwards Lifesciences, LLC	2025	0
K101212	Medtronic Contour 3D Annuloplasty Ring, Model 690R	Medtronic, Inc.	2010	0

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.
Of its descendants, K103520 (Edwards Lifesciences, LLC, 2011) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K923367.

How does its category compare?

All KRH devices

KRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRH

4in 2025

2007high 8 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRH

98in 2025

2007high 98 (2025) · low 68 (2009)2026

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

2007high 1,288 (2008) · low 73 (2014)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	MAUDE reports
2007	4	90	261
2008	2	—	1,288
2009	8	68	973
2010	2	—	630
2011	2	—	321
2012	0	—	90
2013	0	—	97
2014	1	—	73
2015	0	—	145
2016	1	—	347
2017	0	—	379
2018	2	—	378
2019	2	—	349
2020	2	—	340
2021	0	—	423
2022	0	—	372
2023	2	—	324
2024	1	—	407
2025	4	98	420
2026	2	—	—

What is it indicated for?

The Edwards® MC® Tricuspid Annuloplasty System is intended for use in patients to correct annular dilatation, increase leaftet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

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/K020864 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020864

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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