510(k) · Cleared

Cleared

Cook Fetal Membrane Manipulator, Model -FMM-122400

K082939510(k) TraditionalCleared Sep 3, 2009336-day reviewClass II21 CFR 884.4530

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

Cook Urological, Inc. · KNA Instrument, Manual, Specialized Obstetric-Gynecologic

Cleared on Sep 3, 2009 as substantially equivalent to K941458 (Zinnanti Surgical Instruments, Inc., 1995) after a 336-day review. Its family tree reaches back 1 generation to 1995.

Decided: Sep 3, 2009
Review: 336 days
Class: Class II
Product code: KNA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941458 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK941458 Uterine Manipulator/Injector with SpringZinnanti Surgical Instruments, Inc. · 1995
This deviceK082939 Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941458	Uterine Manipulator/Injector with Spring	Zinnanti Surgical Instruments, Inc.	1995	—
0 (this device)	K082939	Cook Fetal Membrane Manipulator, Model -FMM-122400	Cook Urological, Inc.	2009	—

FIG. 1 — Lineage of K082939, 1995–2009Source: 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 KNA? 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? (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
*	K941458	Uterine Manipulator/Injector with Spring Summary page 1 …xempt, cervical needles are listed'with FDA). The device:is also equivalent to the ZUM'IIMZinnanti Uterine manipulatormanufactured by CooperSurgical (K941458). Device Description: The Cook® Fetal Membrane Manipulatoris used to atraumatically push and-position emergi…	Zinnanti Surgical Instruments, Inc.	1995	—

Also cleared against K941458: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K941458.

How does its category compare?

All KNA devices

KNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KNA

1in 2014

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNA

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

Recalls per year · KNA

No recall names KNA since 2007.

Adverse event reports per year · KNA

5in 2025

2007high 63 (2018) · low 0 (2008)2025

MAUDE reports naming product code KNA, 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	0	—	2
2008	0	—	0
2009	1	—	0
2010	1	—	8
2011	1	—	13
2012	0	—	8
2013	0	—	2
2014	1	—	4
2015	0	—	8
2016	0	—	22
2017	0	—	37
2018	0	—	63
2019	0	—	5
2020	0	—	0
2021	0	—	2
2022	0	—	4
2023	0	—	2
2024	0	—	1
2025	0	—	5
2026	0	—	—

What is it indicated for?

The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082939 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082939: Cook Fetal Membrane Manipulator, Model -FMM-122400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082939

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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