510(k) · Cleared

Cleared

Physio Flex Annuloplasty Ring

K192762510(k) TraditionalCleared Dec 16, 201977-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 Dec 16, 2019 as substantially equivalent to K083470 (Edwards Lifesciences, LLC, 2009) after a 77-day review. Its family tree reaches back 2 generations to 1993.

Decided: Dec 16, 2019
Review: 77 days
Class: Class II
Product code: KRH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K926138 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
1 generation backK083470 Carpentier- Edwards Physio II Annuloplasty, Model 5200Edwards Lifesciences, LLC · 2009
This deviceK192762 Physio Flex Annuloplasty RingEdwards Lifesciences, LLC · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926138	Carpentier-Edwards Physio Annuloplasty Ring	Baxter Healthcare Corp	1993	—
−1	K083470	Carpentier- Edwards Physio II Annuloplasty, Model 5200	Edwards Lifesciences, LLC	2009	—
0 (this device)	K192762	Physio Flex Annuloplasty Ring	Edwards Lifesciences, LLC	2019	—

FIG. 1 — Lineage of K192762, 1993–2019Source: 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

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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
*	K083470	Carpentier- Edwards Physio II Annuloplasty, Model 5200 Summary page 4 …nuloplasty ring Classification Name: 21 CFR Part 870.3800, Product Code KRH, Class II (Special Controls) Predicate Device: K083470 Carpentier-Edwards Physio II annuloplasty ring, model 5200 The Physio Flex annuloplasty ring is a…	Edwards Lifesciences, LLC	2009	—

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 26 years and passes through 2 companies; a new generation was cleared every 15.6 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All KRH devices

KRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

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 Physio Flex Annuloplasty Ring, model 5300, is indicated for the correction of mitral valve insufficiency, or mixed mitral insufficiency, where treatment does not necessitate replacement of the natural mitral valve.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K192762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192762: Physio Flex Annuloplasty Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192762

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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