510(k) · Cleared
ClearedSJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size)
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 Jan 4, 2002 as substantially equivalent to K961246 (St. Jude Medical, Inc., 1997) after a 28-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Jan 4, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961246 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961246 SJM Seguin Annuloplasty Ring Model Sar-MSt. Jude Medical, Inc. · 1997
- This deviceK014037 SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size)St. Jude Medical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK092310 Seguin Annuloplasty RingSt Jude Medical · 2009
- Descendant · 2 generations on · 0 of its ownK253232 Seguin Annuloplasty RingAbbott Medical · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961246 | SJM Seguin Annuloplasty Ring Model Sar-M | St. Jude Medical, Inc. | 1997 | — |
| 0 (this device) | K014037 | SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size) | St. Jude Medical, Inc. | 2002 | — |
| +1 | K092310 | Seguin Annuloplasty Ring | St Jude Medical | 2009 | — |
| +2 | K253232 | Seguin Annuloplasty Ring | Abbott Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K961246 | SJM Seguin Annuloplasty Ring Model Sar-MSummary page 2…racteristics Substantially Equivalent D. Summary of Non-Clinical Tests The testing for the Seguin ring model SAR (predicate) is included in the premarket notification (K961246). The following tests have been performed on the Seguin ring model SARP to insure substantial equivalence with the predicate. Ne… | 1997 |
| * | — | Seguin ring model SAR Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092310 | Seguin Annuloplasty Ring | 2009 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K092310 (St Jude Medical, 2009) has gone furthest, with 1 descendant 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 SJM® Seguin annuloplasty ring is indicated for use in the repair of a mitral
valve that is diseased or damaged due to acquired or congenital processes.
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/K014037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014037: SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014037
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026