510(k) · Cleared
ClearedAts Simulus Adjustable Flexible Annuloplasty Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesee Biomedical, Inc. · KRH Ring, Annuloplasty
Cleared on Jul 31, 2007 as substantially equivalent to K052565 (Genesee Biomedical, Inc., 2005) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jul 31, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K905175 (1992). 3 ancestors in all, the oldest K801879 (1980). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905175 | Pti Annuloplasty Ring (Sterile) | Pioneering Technologies, Inc. | 1992 | — |
| −1 | K052565 | Ats Simulus Annuloplasty Ring, Model 700FF | Genesee Biomedical, Inc. | 2005 | — |
| 0 (this device) | K071214 | Ats Simulus Adjustable Flexible Annuloplasty Ring | Genesee Biomedical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052565 | Ats Simulus Annuloplasty Ring, Model 700FFSummary page 1…Panel Product Code(s): KRH 4. Equivalent Predicate Device: Genesee Biomedical Inc's. SJMULUS Tm Fully Flexible Annuloplasty Ring Model 700FF (K052565) and Genesee Biomedical Inc's. Sculptor®~ Adjustable Annuloplasty Ring Model 605M, & Tricuspid Annuloplasty Ring Models 6… | 2005 |
| * | K905175 | Pti Annuloplasty Ring (Sterile)Summary page 1…sty Ring Model 700FF (K052565) and Genesee Biomedical Inc's. Sculptor®~ Adjustable Annuloplasty Ring Model 605M, & Tricuspid Annuloplasty Ring Models 605T (K905 175). The device is also equivalent to the Puig Massana-Shiley Annuloplasty Ring (K801 876 and K821258). Equivale… | 1992 |
| * | K801879 | Puig Massana-Shiley Annuloplasty Ring Our reading of the summary gave K801876, FDA’s number for Strep B Polyvalent Fluoro-Kit (Clinical Sciences, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Puig Massana-Shiley Annuloplasty Ring”. | 1980 |
| Kept off the family tree | K821258 | FDA’s K821258 is Selopor Our reading of the summary gave K821258, FDA’s number for Selopor (Selomas, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Puig Massana-Shiley Annuloplasty Ring”. Kept off the family tree. Summary page 1…ng Model 605M, & Tricuspid Annuloplasty Ring Models 605T (K905 175). The device is also equivalent to the Puig Massana-Shiley Annuloplasty Ring (K801 876 and K821258). Equivalence can be seen in the design, material composition, surgical technique and intended use. 5. Device… | 1982 |
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 15 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K052565.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ATS SIMULUS Adjustable Flexible Annuloplasty Rings Model 735AF are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071214: Ats Simulus Adjustable Flexible Annuloplasty Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071214
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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