510(k) · Cleared
ClearedSimplici-T Annuloplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Heart Valves · KRH Ring, Annuloplasty
Cleared on Jan 11, 2006 as substantially equivalent to K032810 (Medtronic Heart Valves, 2003) after a 79-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Jan 11, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K893678 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK893678 Duran Flexible Annuloplasty Ring & Obturator H601HMedtronic Blood Systems, Inc. · 1989
- 2 generations backK980534 Duran Flexible Annuloplasty Ring Model Number H608HThe Heart Valve Div. Medtronic Cardiovascular Surg · 1998
- 1 generation backK032810 Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model…Medtronic Heart Valves · 2003
- This deviceK052970 Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006
- Descendant · cites it directly · 0 of its ownK103812 Mitra-LiftSciencity Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103812Mitra-LiftSciencity Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893678 | Duran Flexible Annuloplasty Ring & Obturator H601H | Medtronic Blood Systems, Inc. | 1989 | — |
| −2 | K980534 | Duran Flexible Annuloplasty Ring Model Number H608H | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998 | — |
| −1 | K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B)… | Medtronic Heart Valves | 2003 | — |
| 0 (this device) | K052970 | Simplici-T Annuloplasty System | Medtronic Heart Valves | 2006 | — |
| +1 | K103812 | Mitra-Lift | Sciencity Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore…Summary page 1…Device Model # FDA Clearance Duran Band H607H) K032810 Duran Ring/Band 610R & 610B same Duran AnCore Ring/Band… | 2003 |
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 |
|---|---|---|---|
| K103812 | Mitra-Lift | 2011 | 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 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103812 (Sciencity Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032810.
How does its category compare?
All KRH devicesKRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Simplici-TTM Annuloplasty System is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052970: Simplici-T Annuloplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052970
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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