510(k) · Cleared

Cleared

C3 External Male Bladder Control Device

K974040510(k) TraditionalCleared Jul 14, 1998263-day reviewClass I21 CFR 876.5160

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

Cleared on Jul 14, 1998 as substantially equivalent to K885323 (Dacomed Corp., 1989) and 1 other predicate after a 263-day review. Its family tree reaches back 1 generation to 1985.

Decided: Jul 14, 1998
Review: 263 days
Class: Class I
Product code: FHA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K844445 (1985). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK844445 Revive SystemRevive Systems Corp. · 1985
This deviceK974040 C3 External Male Bladder Control DeviceTimm Research Co. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K844445	Revive System	Revive Systems Corp.	1985	—
0 (this device)	K974040	C3 External Male Bladder Control Device	Timm Research Co.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0

FIG. 1 — Lineage of K974040, 1985–1998Source: 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 FHA? 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? (2)

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
*	K885323	Dacomed External Male Continence Device Summary page 1 …is identical to Timm Research Company’s C3® Male Continence Device, which is a prescription only, urological clamp for males for the management of urinary incontinence (K885323). The OTC C3® Device is identical to Timm Research Company’s prescription C3® Device (K885323) in design, function, materials, an…	Dacomed Corp.	1989	—
*	K844445	Revive System Summary page 1 …® Device does not raise any new questions of safety and efficacy. An example of an OTC constriction ring is the Revive System manufactured by Revive Systems Corporation (K844445). page 9 DEVICE DESCRIPTION: INTENDED USE: FUNCTIONAL & SAFETY TESTING: CONCLUSION: {CRETETS A2 The C3® Exte…	Revive Systems Corp.	1985	—

Also cleared against K885323: 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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K885323.

How does its category compare?

All FHA devices

FHA Clamp, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHA

FDA has decided no FHA device since 2007.

Median 510(k) review, days · FHA

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

Recalls per year · FHA

No recall names FHA since 2007.

Adverse event reports per year · FHA

1in 2023

2007high 5 (2014) · low 0 (2007)2025

MAUDE reports naming product code FHA, 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	—	1
2011	—	0
2012	—	1
2013	—	1
2014	—	5
2015	—	0
2016	—	0
2017	—	5
2018	—	5
2019	—	3
2020	—	1
2021	—	0
2022	—	2
2023	—	1
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The C3® External Male Bladder Control Device is intended to be used for the

management of urinary incontinence in males.

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/K974040 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974040: C3 External Male Bladder Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974040

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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