510(k) · Cleared
ClearedMedtronic Colvin-Galloway Future Annuloplasty Band, Model 638B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · KRH Ring, Annuloplasty
Cleared on Jul 12, 2001 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- KRH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK011395 Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638BMedtronic Vascular · 2001
- Descendant · cites it directly · 3 of its ownK052860 CG Future Annuloplasty BandMedtronic Heart Valves · 2005
- Descendant · 2 generations on · 1 of its ownK061127 CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006
- Descendant · cites it directly · 0 of its ownK070488 Micardia Annuloplasty Band DRMicardia Corporation · 2008
- Descendant · 3 generations on · 0 of its ownK073324 Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K052860CG Future Annuloplasty BandMedtronic Heart Valves · 2005 · cites it directly3descendants
- K061127CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006 · 2 generations on1descendant
- K070488Micardia Annuloplasty Band DRMicardia Corporation · 2008 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K011395 | Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B | Medtronic Vascular | 2001 | — |
| +1 | K052860 | CG Future Annuloplasty Band | Medtronic Heart Valves | 2005 | — |
| +2 | K061127 | CG Future Annuloplasty System, Model 638R | Medtronic Vascular | 2006 | — |
| +1 | K070488 | Micardia Annuloplasty Band DR | Micardia Corporation | 2008 | — |
| +3 | K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680R | Medtronic, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K052860 (Medtronic Heart Valves, 2005) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K011395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011395: Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011395
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026