# K130951: SIM

- Pathway: 510(k) (Traditional)
- Applicant: Simavita Pty Limited
- Decided: Aug 22, 2013 after 139 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 K943559 (1995). 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)
- K943559: Remote A'lert, Health Sense Intl., Inc. (1995) Summary page 1.

## Indications for use
SIM h (Smart Incontinence Management) Is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g.. hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.

Source page: https://510kreport.com/device/K130951
Methodology: https://510kreport.com/methodology