510(k) · Cleared
ClearedAts Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC
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 15, 2010 as substantially equivalent to K072655 (Genesee Biomedical, Inc., 2007) after a 205-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Jul 15, 2010
- Review
- 205 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905175 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
- 1 generation backK072655 Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc. · 2007
- This deviceK093903 Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK230679 WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230679WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc. · 2023 · cites it directly0descendants
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 | K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR | Genesee Biomedical, Inc. | 2007 | — |
| 0 (this device) | K093903 | Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC | Genesee Biomedical, Inc. | 2010 | — |
| +1 | K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRSummary page 1…Product Code(s): KRH 4. Equivalent Predicate Device: Genesee Biomedical Inc's. ATS SIMULUSO Semi-Flexible Tricuspid Annuloplasty Ring Model 800SR (K072655). Equivalence can be seen in the design, material composition, surgical technique and intended use. 5. Device Descripti… | 2007 |
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 |
|---|---|---|---|
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | 2023 | 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 18 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230679 (Genesee Biomedical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072655.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 TRI-ADTM Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for
use in those patients undergoing surgery of diseased or damaged 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 tricuspid annulus and restrict
expansion of the annulus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093903: Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093903
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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