510(k) · Cleared
ClearedSJM Tailor Annuloplasty Ring Model Tarp- (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 15, 2002 as substantially equivalent to K000119 (St. Jude Medical, Inc., 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Jan 15, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000119 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000119 SJM Tailor Annuloplasty Ring, Model TarnSt. Jude Medical, Inc. · 2000
- This deviceK014161 SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK083835 Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical · 2009
- Descendant · 2 generations on · 0 of its ownK092876 SJM Attune Annuloplasty RingSt Jude Medical · 2009
- Descendant · cites it directly · 0 of its ownK022363 SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See all- K083835Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical · 2009 · cites it directly1descendant
- K092876SJM Attune Annuloplasty RingSt Jude Medical · 2009 · 2 generations on0descendants
- K022363SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)St. Jude Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000119 | SJM Tailor Annuloplasty Ring, Model Tarn | St. Jude Medical, Inc. | 2000 | — |
| 0 (this device) | K014161 | SJM Tailor Annuloplasty Ring Model Tarp- (Size) | St. Jude Medical, Inc. | 2002 | — |
| +1 | K083835 | Attune Adjustable Flexible Annuloplasty Ring Model Afr | St Jude Medical | 2009 | — |
| +2 | K092876 | SJM Attune Annuloplasty Ring | St Jude Medical | 2009 | — |
| +1 | K022363 | SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band) | St. Jude Medical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K000119 | SJM Tailor Annuloplasty Ring, Model TarnSummary page 2…acteristics Substantially Equivalent D. Summary of Non-Clinical Tests The testing for the Tailor ring model TARN (predicate) is included in the premarket notification (K000119). The following tests have been performed on the Tailor ring model TARP to insure substantial equivalence with the predicate. Ne… | 2000 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K083835 (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® Tailor™ annuloplasty ring is indicated for use in the repair of a mitral or tricuspid 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/K014161 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014161: SJM Tailor Annuloplasty Ring Model Tarp- (Size).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014161
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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