# K021446: Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with Mask and Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Oemedic International, Inc.
- Decided: Oct 11, 2002 after 158 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- 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 OEMedic International Inc. BesmedG3 Silicone Manual Resuscitators are intended to provide emergency ventilation or ventilation during patient transport, with air or air enriched with oxygen. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.

Source page: https://510kreport.com/device/K021446
Methodology: https://510kreport.com/methodology