# K032596: Sturdy Manual Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Sturdy Industrial Co., Ltd.
- Decided: Aug 5, 2004 after 349 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without added oxygen. The child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30kg.

Source page: https://510kreport.com/device/K032596
Methodology: https://510kreport.com/methodology