510(k) · Cleared
ClearedAts Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR
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 Oct 23, 2007 as substantially equivalent to K905175 (Pioneering Technologies, Inc., 1992) after a 33-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.
- Decided
- Oct 23, 2007
- Review
- 33 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905175 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
- This deviceK072655 Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK232599 TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK093903 Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK250859 TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230679 WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK201449 SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty…Medtronic, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2024 · cites it directly1descendant
- K093903Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 2010 · cites it directly1descendant
- K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2025 · 2 generations on0descendants
- K230679WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc. · 2023 · 2 generations on0descendants
- K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm…Medtronic, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905175 | Pti Annuloplasty Ring (Sterile) | Pioneering Technologies, Inc. | 1992 | — |
| 0 (this device) | K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR | Genesee Biomedical, Inc. | 2007 | — |
| +1 | K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2024 | — |
| +1 | K093903 | Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC | Genesee Biomedical, Inc. | 2010 | — |
| +2 | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2025 | — |
| +2 | K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | 2023 | — |
| +1 | K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band… | Medtronic, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K905175 | Pti Annuloplasty Ring (Sterile)Summary page 1…lar Devices Panel Product Code(s): KRH 4. Equivalent Predicate Device: Genesee Biomedical Inc's. Sculptor® Semi-Rigid Mitral Annuloplasty Ring Model 605M (K905 175). Equivalence can be seen in the design, material composition, surgical technique and intended use. 5. Device Description:… | 1992 |
What descends from it? (5)
3 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?
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 SIMULUSTM Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral 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 annulus and restrict expansion of the annulus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072655
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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