510(k) · Cleared
ClearedAttune Adjustable Flexible Annuloplasty Ring Model Afr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · KRH Ring, Annuloplasty
Cleared on Jan 23, 2009 as substantially equivalent to K014161 (St. Jude Medical, Inc., 2002) after a 31-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jan 23, 2009
- Review
- 31 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000119 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000119 SJM Tailor Annuloplasty Ring, Model TarnSt. Jude Medical, Inc. · 2000
- 1 generation backK014161 SJM Tailor Annuloplasty Ring Model Tarp- (Size)St. Jude Medical, Inc. · 2002
- This deviceK083835 Attune Adjustable Flexible Annuloplasty Ring Model AfrSt Jude Medical · 2009
- Descendant · cites it directly · 0 of its ownK092876 SJM Attune Annuloplasty RingSt Jude Medical · 2009
Most influential descendants
Showing 1 of 1 · See all- K092876SJM Attune Annuloplasty RingSt Jude Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000119 | SJM Tailor Annuloplasty Ring, Model Tarn | St. Jude Medical, Inc. | 2000 | — |
| −1 | K014161 | SJM Tailor Annuloplasty Ring Model Tarp- (Size) | St. Jude Medical, Inc. | 2002 | — |
| 0 (this device) | K083835 | Attune Adjustable Flexible Annuloplasty Ring Model Afr | St Jude Medical | 2009 | — |
| +1 | K092876 | SJM Attune Annuloplasty Ring | St Jude Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K014161 | SJM Tailor Annuloplasty Ring Model Tarp- (Size)Summary page 4…Class II per 21 CFR 870.3800, Annuloplasty rings Predicate Device: Tailor Annuloplasty Ring Model TARP-(size) - 510 (k) K014161 Device Description: The Attune™ Adjustable Flexible Annuloplasty Ring is a fully flexible ring fabricated with a medical grade s… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092876 | SJM Attune Annuloplasty Ring | 2009 | 0 |
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 9 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092876 (St Jude Medical, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K014161.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Attune™ Adjustable Flexible 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 valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the Attune™ Adjustable Flexible Annuloplasty Ring
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083835: Attune Adjustable Flexible Annuloplasty Ring Model Afr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083835
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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