510(k) · Cleared
ClearedTransForm McCarthy Mitral Annuloplasty Ring (TF)
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 25, 2025 as substantially equivalent to K232599 (Genesee Biomedical, Inc., 2024) after a 126-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jul 25, 2025
- Review
- 126 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905175 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
- 2 generations backK072655 Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc. · 2007
- 1 generation backK232599 TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2024
- This deviceK250859 TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905175 | Pti Annuloplasty Ring (Sterile) | Pioneering Technologies, Inc. | 1992 | — |
| −2 | 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 | — |
| 0 (this device) | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF)Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K232599 1 1 TransForm TM McCarthy Annuloplasty Ring (TF) 1 1 KRH… | 2024 |
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 33 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
TransForm™ McCarthy Mitral Annuloplasty Ring (TF) is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250859
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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