510(k) · Cleared

Cleared

CG Future Annuloplasty Band

K052860510(k) SpecialCleared Nov 10, 200530-day reviewClass II21 CFR 870.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Heart Valves · KRH Ring, Annuloplasty

Cleared on Nov 10, 2005 as substantially equivalent to K011395 (Medtronic Vascular, 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.

Decided: Nov 10, 2005
Review: 30 days
Class: Class II
Product code: KRH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011395 (2001). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK011395 Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638BMedtronic Vascular · 2001
This deviceK052860 CG Future Annuloplasty BandMedtronic Heart Valves · 2005
Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK073324 Medtronic Profile 3D Annuloplasty Ring, Model 680RMedtronic, Inc. · 2008

Most influential descendants

Showing 3 of 3 · See all

K061127CG Future Annuloplasty System, Model 638RMedtronic Vascular · 2006 · cites it directly1descendant
K070488Micardia Annuloplasty Band DRMicardia Corporation · 2008 · cites it directly0descendants
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
−1	K011395	Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B	Medtronic Vascular	2001	—
0 (this device)	K052860	CG Future Annuloplasty Band	Medtronic Heart Valves	2005	—
+1	K061127	CG Future Annuloplasty System, Model 638R	Medtronic Vascular	2006	—
+1	K070488	Micardia Annuloplasty Band DR	Micardia Corporation	2008	—
+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	1	0
2008	2	0

FIG. 1 — Lineage of K052860, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K011395	Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B	Medtronic Vascular	2001	—

Also cleared against K011395: 1 other device →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061127	CG Future Annuloplasty System, Model 638R	Medtronic Vascular	2006	1
K070488	Micardia Annuloplasty Band DR	Micardia Corporation	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?

Its one ancestor has no recall.
Of its descendants, K061127 (Medtronic Vascular, 2006) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K011395.

How does its category compare?

All KRH devices

KRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRH

4in 2025

2007high 8 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRH

98in 2025

2007high 98 (2025) · low 68 (2009)2026

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

2007high 1,288 (2008) · low 73 (2014)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	MAUDE reports
2007	4	90	261
2008	2	—	1,288
2009	8	68	973
2010	2	—	630
2011	2	—	321
2012	0	—	90
2013	0	—	97
2014	1	—	73
2015	0	—	145
2016	1	—	347
2017	0	—	379
2018	2	—	378
2019	2	—	349
2020	2	—	340
2021	0	—	423
2022	0	—	372
2023	2	—	324
2024	1	—	407
2025	4	98	420
2026	2	—	—

What is it indicated for?

The CG Future® Annuloplasty 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/K052860 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052860: CG Future Annuloplasty Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052860

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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