510(k) · Cleared
ClearedCarpentier- Edwards Physio II Annuloplasty, Model 5200
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 Jan 23, 2009 as substantially equivalent to K926138 (Baxter Healthcare Corp, 1993) after a 60-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Jan 23, 2009
- Review
- 60 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926138 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
- This deviceK083470 Carpentier- Edwards Physio II Annuloplasty, Model 5200Edwards Lifesciences, LLC · 2009
- Descendant · cites it directly · 0 of its ownK192762 Physio Flex Annuloplasty RingEdwards Lifesciences, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC · 2019 · cites it directly0descendants
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) | K083470 | Carpentier- Edwards Physio II Annuloplasty, Model 5200 | Edwards Lifesciences, LLC | 2009 | — |
| +1 | K192762 | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 1…Class II, CFR 870 3800 Annuloplasty Ring, KRH Predicate Device(s) Carpentier-Edwards Physio'" Annuloplasty Ring (K926138) Device Description The Carpentier-Edwards Physio II annuloplasty ring, model 5200,… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192762 | Physio Flex Annuloplasty Ring | 2019 | 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?
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 IIAnnuloplasty 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 The Carpentier-Edwards Physio IIAnnuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional…
Read the full statement (256 words)
The Carpentier-Edwards Physio IIAnnuloplasty 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
The Carpentier-Edwards Physio IIAnnuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole
The decision to undertake annuloplasty can be made only after visual analysis of the lesion present The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae
The remodeling annuloplasty technique with a Carpentier-Edwards Physio IIAnnuloplasty Ring, Model 5200, may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue
For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient However, the ring technique must be associated with mitral valvuloplasty repair in Type IIinsufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083470 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083470: Carpentier- Edwards Physio II Annuloplasty, Model 5200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083470
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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