510(k) · Cleared

Cleared

Ats Simulus Annuloplasty Band, Model 700FC

K052899510(k) SpecialCleared Nov 17, 200534-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

Genesee Biomedical, Inc. · KRH Ring, Annuloplasty

Cleared on Nov 17, 2005 as substantially equivalent to K905175 (Pioneering Technologies, Inc., 1992) after a 34-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Nov 17, 2005
Review: 34 days
Class: Class II
Product code: KRH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K905175 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK905175 Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
This deviceK052899 Ats Simulus Annuloplasty Band, Model 700FCGenesee Biomedical, Inc. · 2005
Descendant · cites it directly · 0 of its ownK201449 SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty…Medtronic, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm…Medtronic, Inc. · 2020 · cites it directly0descendants

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)	K052899	Ats Simulus Annuloplasty Band, Model 700FC	Genesee Biomedical, Inc.	2005	—
+1	K201449	SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band…	Medtronic, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K052899, 1992–2020Source: 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
*	K905175	Pti Annuloplasty Ring (Sterile) Summary page 1 …Class II Classification Panel: Cardiovascular Devices Panel Product Code(s): KRH 4 Equivalent Predicate Device: K905175, PTI Annuloplasty Ring (Sterile), Now called the Genesee BioMedical, Inc. Sculptors Annuloplasty Ring. Equivalence…	Pioneering Technologies, Inc.	1992	—

Also cleared against K905175: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K201449	SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm…	Medtronic, Inc.	2020	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, K201449 (Medtronic, Inc., 2020) has gone furthest, with 0 descendants of its own.
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?

The Genesee BioMedical ATS SIMULUS 700FC Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052899 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052899: Ats Simulus Annuloplasty Band, Model 700FC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052899

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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