510(k) · Cleared
ClearedProsthetic Rings #4400 Mitral & 4500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Edwards Laboratories · KRH Ring, Annuloplasty
Cleared on Jul 29, 1983 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 29, 1983
- Review
- 43 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK831949 Prosthetic Rings #4400 Mitral & 4500American Edwards Laboratories · 1983
- Descendant · cites it directly · 3 of its ownK032250 Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC · 2003
- Descendant · 2 generations on · 0 of its ownK083623 Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC · 2009
- Descendant · cites it directly · 0 of its ownK083191 Detlogix Annuloplasty Ring, Model: 5100Edwards Lifesciences, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK042734 SJM Rigid Saddle Ring Model Rsar-(Size)St. Jude Medical, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K032250Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC · 2003 · cites it directly3descendants
- K083623Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC · 2009 · 2 generations on0descendants
- K083191Detlogix Annuloplasty Ring, Model: 5100Edwards Lifesciences, LLC · 2009 · cites it directly0descendants
- K042734SJM Rigid Saddle Ring Model Rsar-(Size)St. Jude Medical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831949 | Prosthetic Rings #4400 Mitral & 4500 | American Edwards Laboratories | 1983 | — |
| +1 | K032250 | Geoform Annuloplasty Ring, Mitral Model 4200 | Edwards Lifesciences, LLC | 2003 | — |
| +2 | K083623 | Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 | Edwards Lifesciences, LLC | 2009 | — |
| +1 | K083191 | Detlogix Annuloplasty Ring, Model: 5100 | Edwards Lifesciences, LLC | 2009 | — |
| +2 | K042734 | SJM Rigid Saddle Ring Model Rsar-(Size) | St. Jude Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 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? (4)
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, K032250 (Edwards Lifesciences, LLC, 2003) 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/K831949 · printed Nov 5, 2026
Cite this page
510(k) Report. “K831949: Prosthetic Rings #4400 Mitral & 4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K831949
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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