510(k) · Cleared
ClearedTruForm Sievers 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 Oct 6, 2020 as substantially equivalent to K190506 (Genesee Biomedical, Inc., 2019) after a 57-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Oct 6, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190506 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK190506 NeoForm Annuloplasty RingGenesee Biomedical, Inc. · 2019
- This deviceK202253 TruForm Sievers Annuloplasty RingGenesee Biomedical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | 2019 | — |
| 0 (this device) | K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K190506 | NeoForm Annuloplasty RingSummary page 4…Cardiovascular Predicate Device The subject device is substantially equivalent to the NeoForm™ Annuloplasty Ring, Model 4200 (K190506) Reference Devices K161815 - FlexForm Annuloplasty Ring K905175 - Sculptor Annuloplasty Ring… | 2019 |
| † | K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | 2016 |
| † | K905175 | Pti Annuloplasty Ring (Sterile) | 1992 |
| † | K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR | 2007 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 TruForm Sievers Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202253: TruForm Sievers 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/K202253
Report an extraction error
Are you the manufacturer?
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