# K971442: Hughes Bladder and Bowel Training System (AD-T-18, Med-18,Med-1,Med-T-1,Medd-18,Med-38,Med-T-10,Med-T-25,Med-T-5

- Pathway: 510(k) (Traditional)
- Applicant: Humed, Inc.
- Decided: Jan 8, 1998 after 262 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the contral of incontinence. Hughes Bowel and Bladder System model MeD-18 helps persons with incontinence manage aor overcome bladder contral problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins. Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their conditon promptly and with complete discretian at the first sign of bladder or bowel release day ar night.

Source page: https://510kreport.com/device/K971442
Methodology: https://510kreport.com/methodology