510(k) · Decided
DecidedCosgrove Edwards Annuloplasty System, Model 4600
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 Jan 6, 1993 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jan 6, 1993
- Review
- 181 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK923367 Cosgrove Edwards Annuloplasty System, Model 4600Baxter Healthcare Corp · 1993
- Descendant · cites it directly · 10 of its ownK020864 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 · cites it directly · 1 of its ownK033685 Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 2004
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K020864Edwards MC Tricuspid Annuloplasty System, Model 4900Edwards Lifesciences, LLC · 2002 · cites it directly10descendants
- 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
- K033685Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923367 | Cosgrove Edwards Annuloplasty System, Model 4600 | Baxter Healthcare Corp | 1993 | — |
| +1 | 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 | — |
| +1 | K033685 | Northrup Universal Annuloplasty System, Model 1000 | Medical Cv, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 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? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020864 | Edwards MC Tricuspid Annuloplasty System, Model 4900 | 2002 | 10 |
| K103520 | Carpentier-Edwards Physio Tricuspid Annuloplasty Ring | 2011 | 3 |
| K032250 | Geoform Annuloplasty Ring, Mitral Model 4200 | 2003 | 3 |
| K033685 | Northrup Universal Annuloplasty System, Model 1000 | 2004 | 1 |
| K071281 | Uniring - Annuloplasty Ring with Sizers | 2007 | 0 |
| K984435 | Medtronic Khonsari Annuloplasty Band, Model H609M | 1999 | 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, K020864 (Edwards Lifesciences, LLC, 2002) has gone furthest, with 10 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/K923367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923367: Cosgrove Edwards Annuloplasty System, Model 4600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923367
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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