510(k) · Cleared

Cleared

Millennium Valve Introducer/Rotator Handle

K980016510(k) TraditionalCleared Aug 7, 1998217-day reviewClass I21 CFR 870.3935

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

Genzyme Surgical Product (Genzyme Biosurgery) · MOP Rotator, Prosthetic Heart Valve

Cleared on Aug 7, 1998 as substantially equivalent to K960400 (Snowden-Pencer, 1996) and 2 other predicates after a 217-day review. Its family tree reaches back 2 generations to 1994.

Decided: Aug 7, 1998
Review: 217 days
Class: Class I
Product code: MOP
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K930667 (1994). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
1 generation backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
This deviceK980016 Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930667	Reusable Laparoscopic Instruments	Snowden-Pencer	1994	15
−1	K960400	Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…	Snowden-Pencer	1996	—
0 (this device)	K980016	Millennium Valve Introducer/Rotator Handle	Genzyme Surgical Product (Genzyme Biosurgery)	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	1	0
1996	1	0

FIG. 1 — Lineage of K980016, 1994–1998Source: 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 MOP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K960400	Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port… Summary page 1 …me: Introducer/Rotator Handle Classification Name: Accessory to Valve Holder or Valve 3. PREDICATE DEVICE Diamond Touch and Micro Diamond Touch/Diamond Line Instruments K960400 Carbomedics Extended Mitral Rotator K951368 Carbomedics Handle K962154 4. DEVICE DESCRIPTION The Millennium Valve Introducer/Rot…	Snowden-Pencer	1996	—
*	K951368	Carbomedics Exended Mitral Rotator Summary page 1 …Name: Accessory to Valve Holder or Valve 3. PREDICATE DEVICE Diamond Touch and Micro Diamond Touch/Diamond Line Instruments K960400 Carbomedics Extended Mitral Rotator K951368 Carbomedics Handle K962154 4. DEVICE DESCRIPTION The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) cons…	Carbomedics, Inc.	1995	—
*	K962154	Carbomedics Handle Summary page 1 …older or Valve 3. PREDICATE DEVICE Diamond Touch and Micro Diamond Touch/Diamond Line Instruments K960400 Carbomedics Extended Mitral Rotator K951368 Carbomedics Handle K962154 4. DEVICE DESCRIPTION The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible…	Carbomedics, Inc.	1996	—

Also cleared against K960400: 3 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?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
1 of the 6 ancestors has a recall of any class.
3 other devices also cite its predicate K960400.

How does its category compare?

All MOP devices

MOP Rotator, Prosthetic Heart Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOP

FDA has decided no MOP device since 2007.

Median 510(k) review, days · MOP

Too few MOP 510(k)s in any year since 2007 to give a median.

Recalls per year · MOP

No recall names MOP since 2007.

Adverse event reports per year · MOP

1in 2014

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code MOP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.

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/K980016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980016: Millennium Valve Introducer/Rotator Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980016

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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