# K974040: C3 External Male Bladder Control Device

- Pathway: 510(k) (Traditional)
- Applicant: Timm Research Co.
- Decided: Jul 14, 1998 after 263 days
- Product code: FHA (Clamp, Penile)
- Device class: 1
- Regulation: 21 CFR 876.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844445 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885323: Dacomed External Male Continence Device, Dacomed Corp. (1989) Summary page 1.
- K844445: Revive System, Revive Systems Corp. (1985) Summary page 1.

## Indications for use
The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.

Source page: https://510kreport.com/device/K974040
Methodology: https://510kreport.com/methodology