510(k) · Cleared
ClearedSimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · KRH Ring, Annuloplasty
Cleared on Jul 1, 2020 as substantially equivalent to K052565 (Genesee Biomedical, Inc., 2005) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jul 1, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K905175 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
- 1 generation backK052565 Ats Simulus Annuloplasty Ring, Model 700FFGenesee Biomedical, Inc. · 2005
- This deviceK201449 SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty…Medtronic, Inc. · 2020
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) | K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band… | Medtronic, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K052565 | Ats Simulus Annuloplasty Ring, Model 700FFSummary page 5…Code Panel Controls SimuPlus™ Simulus™ Flexible Flexible Annuloplasty Ring, Annuloplasty Ring, Model 700FF Model 7700FR (K052565) SimuPlus™ Simulus™ Flexible Flexible Annuloplasty Band, Annuloplasty Ring, 21 CFR… | 2005 |
| * | K052899 | Ats Simulus Annuloplasty Band, Model 700FCSummary page 5…Yes Annuloplasty Band, Model 700FC Ring Annuloplasty 870.3800 Devices Panel Model 7700FB (K052899) SimuForm™ Semi- Simulus™ Semi- Rigid Annuloplasty Rigid Annuloplasty Ring, Model Ring, Model 800SR 7800RR… | 2005 |
| * | K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRSummary page 5…l Model 7700FB (K052899) SimuForm™ Semi- Simulus™ Semi- Rigid Annuloplasty Rigid Annuloplasty Ring, Model Ring, Model 800SR 7800RR (K072655) 1.3 Design and Manufacturing Facility Addresses Design Site: Medtronic Heart Valves Div… | 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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 4 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. 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 SimuPlus flexible annuloplasty ring and band are indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimuPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.
The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201449: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid 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/K201449
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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