510(k) · Cleared
ClearedSJM Seguin Annuloplasty Ring Model Sar-M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Inc. · KRH Ring, Annuloplasty
Cleared on Feb 14, 1997 after a 319-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Feb 14, 1997
- Review
- 319 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK961246 SJM Seguin Annuloplasty Ring Model Sar-MSt. Jude Medical, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK014037 SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size)St. Jude Medical, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK092310 Seguin Annuloplasty RingSt Jude Medical · 2009
- Descendant · 3 generations on · 0 of its ownK253232 Seguin Annuloplasty RingAbbott Medical · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961246 | SJM Seguin Annuloplasty Ring Model Sar-M | St. Jude Medical, Inc. | 1997 | — |
| +1 | K014037 | SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size) | St. Jude Medical, Inc. | 2002 | — |
| +2 | K092310 | Seguin Annuloplasty Ring | St Jude Medical | 2009 | — |
| +3 | K253232 | Seguin Annuloplasty Ring | Abbott Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Carpentier-Edwards Physio™ annuloplasty ring Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014037 | SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size) | 2002 | 2 |
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, K014037 (St. Jude Medical, Inc., 2002) has gone furthest, with 2 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 | — |
What is it indicated for?
The Seguin Annuloplasty Ring is indicated for use in repair of diseased or damaged mitral heart valves that are determined by the Physician to be repairable and do not require replacement. The Seguin Annuloplasty Ring provides support to the mitral heart valve restricting expansion of the annulus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961246 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961246: SJM Seguin Annuloplasty Ring Model Sar-M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961246
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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