# K962416: Drytime for Bladder Control Silent

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Systems Research
- Decided: Jul 22, 1996 after 83 days
- Product code: KPN (Alarm, Conditioned Response Enuresis)
- Device class: 2
- Regulation: 21 CFR 876.2040
- 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 K955338 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955338: Drytime for Potty Training, Health Sense Intl., Inc. (1996) Summary page 2.

## Indications for use
The proposed device, DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist the control of incontinence. It is designed and used in a manner consistent with the predicate device (i.e., the emission of bodily fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm).

Source page: https://510kreport.com/device/K962416
Methodology: https://510kreport.com/methodology