510(k) · Cleared
ClearedCG Future Annuloplasty System, Model 638R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · KRH Ring, Annuloplasty
Cleared on May 23, 2006 as substantially equivalent to K052860 (Medtronic Heart Valves, 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- May 23, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K893678 (1989). 5 ancestors in all. 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 deviceK061127 CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006
- Descendant · cites it directly · 0 of its ownK073324 Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073324Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008 · 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) | K061127 | CG Future Annuloplasty System, Model 638R | Medtronic Vascular | 2006 | — |
| +1 | K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680R | Medtronic, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K052860 | CG Future Annuloplasty BandSummary page 1…elieves the CG Ring is substantially equivalent to the CG Future® Annuloplasty Band (CG Band) previously cleared to market in the U.S. by FDA on November 10, 2005 (K052860) and also the Duran AnCore® Ring and Band (Duran Product Family) previously cleared to market in the U.S. by FDA on December 5… | 2005 |
| * | K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore…Summary page 1…on November 10, 2005 (K052860) and also the Duran AnCore® Ring and Band (Duran Product Family) previously cleared to market in the U.S. by FDA on December 5, 2003 (K0328 10) and may market our device under these equivalencies. Substantial Equivalence The CG Ring has the same fundamental scie… | 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 |
|---|---|---|---|
| K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680R | 2008 | 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 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K073324 (Medtronic, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052860.
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 CG Future® Annuloplasty Ring and Band is indicated for the reconstruction and/or
remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be
corrected by appropriate repair and annular remodeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061127: CG Future Annuloplasty System, Model 638R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061127
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