510(k) · Cleared
ClearedSeguin Annuloplasty Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · KRH Ring, Annuloplasty
Cleared on Oct 29, 2025 as substantially equivalent to K092310 (St Jude Medical, 2009) after a 30-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Oct 29, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961246 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK961246 SJM Seguin Annuloplasty Ring Model Sar-MSt. Jude Medical, Inc. · 1997
- 2 generations backK014037 SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size)St. Jude Medical, Inc. · 2002
- 1 generation backK092310 Seguin Annuloplasty RingSt Jude Medical · 2009
- This deviceK253232 Seguin Annuloplasty RingAbbott Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961246 | SJM Seguin Annuloplasty Ring Model Sar-M | St. Jude Medical, Inc. | 1997 | — |
| −2 | K014037 | SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size) | St. Jude Medical, Inc. | 2002 | — |
| −1 | K092310 | Seguin Annuloplasty Ring | St Jude Medical | 2009 | — |
| 0 (this device) | K253232 | Seguin Annuloplasty Ring | Abbott Medical | 2025 | — |
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 |
|---|---|---|---|
| * | K092310 | Seguin Annuloplasty RingSummary page 5…870.8300 Product Code(s) KRH | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K092310 SJM Seguin Annuloplasty Ring KRH Device Description Summary 21 CFR 807.92(a)(4) The Seguin Annuloplasty Ring (SARP) is a semi-ri… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 the repair of mitral valves that are 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/K253232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253232: Seguin Annuloplasty Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253232
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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