510(k) · Cleared
ClearedDuran Flexible Annuloplasty Ring Model Number H608H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Heart Valve Div. Medtronic Cardiovascular Surg · KRH Ring, Annuloplasty
Cleared on Apr 30, 1998 as substantially equivalent to K893678 (Medtronic Blood Systems, Inc., 1989) after a 78-day review. Its family tree reaches back 1 generation to 1989. 5 later devices descend from it.
- Decided
- Apr 30, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K893678 (1989). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK893678 Duran Flexible Annuloplasty Ring & Obturator H601HMedtronic Blood Systems, Inc. · 1989
- This deviceK980534 Duran Flexible Annuloplasty Ring Model Number H608HThe Heart Valve Div. Medtronic Cardiovascular Surg · 1998
- Descendant · cites it directly · 4 of its ownK032810 Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model…Medtronic Heart Valves · 2003
- Descendant · 2 generations on · 1 of its ownK061127 CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006
- Descendant · 2 generations on · 1 of its ownK052970 Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006
- Descendant · 3 generations on · 0 of its ownK103812 Mitra-LiftSciencity Co., Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK073324 Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K032810Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore…Medtronic Heart Valves · 2003 · cites it directly4descendants
- K061127CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006 · 2 generations on1descendant
- K052970Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006 · 2 generations on1descendant
- K103812Mitra-LiftSciencity Co., Ltd. · 2011 · 3 generations on0descendants
- K073324Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893678 | Duran Flexible Annuloplasty Ring & Obturator H601H | Medtronic Blood Systems, Inc. | 1989 | — |
| 0 (this device) | 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 | — |
| +2 | K061127 | CG Future Annuloplasty System, Model 638R | Medtronic Vascular | 2006 | — |
| +2 | K052970 | Simplici-T Annuloplasty System | Medtronic Heart Valves | 2006 | — |
| +3 | K103812 | Mitra-Lift | Sciencity Co., Ltd. | 2011 | — |
| +3 | K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680R | Medtronic, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K893678 | Duran Flexible Annuloplasty Ring & Obturator H601HSummary page 1…ion Name: Annuloplasty Ring 21 CFR 870.3800 18.3 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k)-No. Date Cleared Medtronic, Inc. Duran Flexible Annuloplasty K893678 11/27/89 Ring and Obturator 141 ......................................... 18.4 18.5 18.6 DEVICE DESCRIPTION… | 1989 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore… | 2003 | 4 |
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.
- Of its descendants, K032810 (Medtronic Heart Valves, 2003) has gone furthest, with 4 descendants of its own.
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 Duran Flexible Annuloplasty Ring is indicated for the reconstruction and/or remodeling of the pathologic mitral and tricuspid valves. Combined atrioventricular valve insufficiency and stenosis may be corrected by appropriate commissurotomy and valvular remodeling.
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/K980534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980534: Duran Flexible Annuloplasty Ring Model Number H608H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980534
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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