510(k) · Cleared

Cleared

Medtronic Khonsari Annuloplasty Band, Model H609M

K984435510(k) SpecialCleared Jan 7, 199927-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 Vascular · KRH Ring, Annuloplasty

Cleared on Jan 7, 1999 as substantially equivalent to K905175 (Pioneering Technologies, Inc., 1992) and 2 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1992.

Decided: Jan 7, 1999
Review: 27 days
Class: Class II
Product code: KRH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K905175 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
This deviceK984435 Medtronic Khonsari Annuloplasty Band, Model H609MMedtronic Vascular · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K905175	Pti Annuloplasty Ring (Sterile)	Pioneering Technologies, Inc.	1992	—
0 (this device)	K984435	Medtronic Khonsari Annuloplasty Band, Model H609M	Medtronic Vascular	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	1	0

FIG. 1 — Lineage of K984435, 1992–1999Source: 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? (3)

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
*	K905175	Pti Annuloplasty Ring (Sterile) Summary page 1 …n Name: Ring, Annuloplasty Class: Pre-amendment Class III Panel: CV (74) KRH I IDENTIFICATION OF PREDICATE DEVICE Device S10(k) # Medtronic SCULPTOR® Annuloplasty Ring K905175 [Model 605M] The 510(k) also includes references to the following marketed devices: Medtronic Posterior Annuloplasty Ring [Mode…	Pioneering Technologies, Inc.	1992	—
*	K960356	Posterior Annuloplasty Band (Model 607) Summary page 1 …ULPTOR® Annuloplasty Ring K905175 [Model 605M] The 510(k) also includes references to the following marketed devices: Medtronic Posterior Annuloplasty Ring [Model 607] K960356 Cosgrove-Edwards™ Annuloplasty System [Model 4600] K923367 Medtronic DURAN Annuloplasty Ring [Model H608H] K980534 Medtronic KIH…	The Heart Valve Div. Medtronic Cardiovascular Surg	1996	—
*	K923367	Cosgrove Edwards Annuloplasty System, Model 4600 Summary page 1 …also includes references to the following marketed devices: Medtronic Posterior Annuloplasty Ring [Model 607] K960356 Cosgrove-Edwards™ Annuloplasty System [Model 4600] K923367 Medtronic DURAN Annuloplasty Ring [Model H608H] K980534 Medtronic KIHONSARI'™ Annuloplasty Band Freaurket Notification [310(k)]…	Baxter Healthcare Corp	1993	—
†	K980534	Duran Flexible Annuloplasty Ring Model Number H608H	The Heart Valve Div. Medtronic Cardiovascular Surg	1998	—

Also cleared against K905175: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 3 ancestors has a recall.
4 other devices also cite its predicate K905175.

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?

For use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.

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/K984435 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984435: Medtronic Khonsari Annuloplasty Band, Model H609M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984435

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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