510(k) · Cleared
ClearedDuran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore
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 Dec 5, 2003 as substantially equivalent to K980534 (The Heart Valve Div. Medtronic Cardiovascular Surg, 1998) after an 87-day review. Its family tree reaches back 2 generations to 1989. 4 later devices descend from it.
- Decided
- Dec 5, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K893678 (1989). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK893678 Duran Flexible Annuloplasty Ring & Obturator H601HMedtronic Blood Systems, Inc. · 1989
- 1 generation backK980534 Duran Flexible Annuloplasty Ring Model Number H608HThe Heart Valve Div. Medtronic Cardiovascular Surg · 1998
- This deviceK032810 Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model…Medtronic Heart Valves · 2003
- Descendant · cites it directly · 1 of its ownK061127 CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006
- Descendant · cites it directly · 1 of its ownK052970 Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006
- Descendant · 2 generations on · 0 of its ownK103812 Mitra-LiftSciencity Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK073324 Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K061127CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006 · cites it directly1descendant
- K052970Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006 · cites it directly1descendant
- K103812Mitra-LiftSciencity Co., Ltd. · 2011 · 2 generations on0descendants
- K073324Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893678 | Duran Flexible Annuloplasty Ring & Obturator H601H | Medtronic Blood Systems, Inc. | 1989 | — |
| −1 | K980534 | Duran Flexible Annuloplasty Ring Model Number H608H | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998 | — |
| 0 (this device) | K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B)… | Medtronic Heart Valves | 2003 | — |
| +1 | K061127 | CG Future Annuloplasty System, Model 638R | Medtronic Vascular | 2006 | — |
| +1 | K052970 | Simplici-T Annuloplasty System | Medtronic Heart Valves | 2006 | — |
| +2 | K103812 | Mitra-Lift | Sciencity Co., Ltd. | 2011 | — |
| +2 | K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680R | Medtronic, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K980534 | Duran Flexible Annuloplasty Ring Model Number H608HSummary page 1…KRH III IDENTIFICATION OF PREDICATE DEVICE Device Model #510(k) Number Duran Ring H608H K980534 32 The 510(k) also… | 1998 |
| † | K893678 | Duran Flexible Annuloplasty Ring & Obturator H601H | 1989 |
| † | K960356 | Posterior Annuloplasty Band (Model 607) | 1996 |
| † | K011395 | Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061127 (Medtronic Vascular, 2006) has gone furthest, with 1 descendant 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 Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves.
Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032810 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032810: Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032810
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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