510(k) · Cleared
ClearedMitra-Lift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sciencity Co., Ltd. · KRH Ring, Annuloplasty
Cleared on May 18, 2011 as substantially equivalent to K052970 (Medtronic Heart Valves, 2006) after a 140-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- May 18, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K893678 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK893678 Duran Flexible Annuloplasty Ring & Obturator H601HMedtronic Blood Systems, Inc. · 1989
- 3 generations backK980534 Duran Flexible Annuloplasty Ring Model Number H608HThe Heart Valve Div. Medtronic Cardiovascular Surg · 1998
- 2 generations backK032810 Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model…Medtronic Heart Valves · 2003
- 1 generation backK052970 Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006
- This deviceK103812 Mitra-LiftSciencity Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K893678 | Duran Flexible Annuloplasty Ring & Obturator H601H | Medtronic Blood Systems, Inc. | 1989 | — |
| −3 | K980534 | Duran Flexible Annuloplasty Ring Model Number H608H | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998 | — |
| −2 | K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B)… | Medtronic Heart Valves | 2003 | — |
| −1 | K052970 | Simplici-T Annuloplasty System | Medtronic Heart Valves | 2006 | — |
| 0 (this device) | K103812 | Mitra-Lift | Sciencity Co., Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K052970 | Simplici-T Annuloplasty SystemSummary page 2…tra-Lift Set S10(K) Submission Sciencity Co., Ltd. The subject device is substantially equivalent to the following predicate devices: ¢ Simplici-T Annuloplasty System (K052970) manufactured by Medtronic Heart Valves (Medtronic). Performance Data Non-clinical laboratory testing was performed demonstrati… | 2006 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.6 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. 2011, 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 Mitra-Lift Set is indicated as reinforcement for repair of the human mitral valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103812: Mitra-Lift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103812
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