510(k) · Decided
DecidedCarpentier-Edwards Physio Annuloplasty Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KRH Ring, Annuloplasty
Cleared on Jun 22, 1993 after a 197-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jun 22, 1993
- Review
- 197 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 7 citing it directly.
- This deviceK926138 Carpentier-Edwards Physio Annuloplasty RingBaxter Healthcare Corp · 1993
- Descendant · cites it directly · 4 of its ownK071327 Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007
- Descendant · 2 generations on · 3 of its ownK142221 MEMO 3D ReChordSorin Group Italia S.R.L. · 2014
- Descendant · 3 generations on · 2 of its ownK180411 MEMO 4DSorin Group Italia S.R.L. · 2018
- Descendant · 2 generations on · 1 of its ownK230318 Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid…Corcym S.r.l. · 2023
- Descendant · cites it directly · 1 of its ownK083470 Carpentier- Edwards Physio II Annuloplasty, Model 5200Edwards Lifesciences, LLC · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K071327Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L. · 2007 · cites it directly4descendants
- K142221MEMO 3D ReChordSorin Group Italia S.R.L. · 2014 · 2 generations on3descendants
- K180411MEMO 4DSorin Group Italia S.R.L. · 2018 · 3 generations on2descendants
- K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…Corcym S.r.l. · 2023 · 2 generations on1descendant
- K083470Carpentier- Edwards Physio II Annuloplasty, Model 5200Edwards Lifesciences, LLC · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926138 | Carpentier-Edwards Physio Annuloplasty Ring | Baxter Healthcare Corp | 1993 | — |
| +1 | K071327 | Memo 3D Semirigid Annuloplasty Ring | Sorin Biomedica Cardio S.R.L. | 2007 | — |
| +2 | K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014 | — |
| +3 | K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018 | — |
| +2 | K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty… | Corcym S.r.l. | 2023 | — |
| +1 | K083470 | Carpentier- Edwards Physio II Annuloplasty, Model 5200 | Edwards Lifesciences, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071327 | Memo 3D Semirigid Annuloplasty Ring | 2007 | 4 |
| K083470 | Carpentier- Edwards Physio II Annuloplasty, Model 5200 | 2009 | 1 |
| K033685 | Northrup Universal Annuloplasty System, Model 1000 | 2004 | 1 |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | 2025 | 0 |
| K083623 | Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 | 2009 | 0 |
| K083191 | Detlogix Annuloplasty Ring, Model: 5100 | 2009 | 0 |
| K071281 | Uniring - Annuloplasty Ring with Sizers | 2007 | 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?
- Of its descendants, K071327 (Sorin Biomedica Cardio S.R.L., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K926138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926138: Carpentier-Edwards Physio 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/K926138
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026