510(k) · Cleared
ClearedAnnuloplasty Rings, Model 4400 Mirtal and 4500 Tri
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 Sep 9, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 9, 1991
- Review
- 90 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK912554 Annuloplasty Rings, Model 4400 Mirtal and 4500 TriBaxter Healthcare Corp · 1991
- Descendant · cites it directly · 3 of its ownK103520 Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC · 2011
- 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 · 3 generations on · 0 of its ownK171431 HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic…Biostable Science & Engineering, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK083623 Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC · 2009
Most influential descendants
Showing 5 of 5 · See all- K103520Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC · 2011 · 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
- K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc. · 2017 · 3 generations on0descendants
- K083623Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912554 | Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri | Baxter Healthcare Corp | 1991 | — |
| +1 | K103520 | Carpentier-Edwards Physio Tricuspid Annuloplasty Ring | Edwards Lifesciences, LLC | 2011 | — |
| +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 | — |
| +3 | K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty… | Biostable Science & Engineering, Inc. | 2017 | — |
| +1 | K083623 | Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 | Edwards Lifesciences, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K103520 (Edwards Lifesciences, LLC, 2011) has gone furthest, with 3 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/K912554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912554: Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912554
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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