# K993194: Rusch Manual Resuscitator Bag

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Mar 24, 2000 after 183 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
Longest line of descent: 1 generation back to K924610 (1993). 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)
- K924610: Baxter Adult/Pedi/Infant Single Use Man Resuscit, Engineered Medical Systems (1993) Summary page 1.

## Indications for use
The Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively

Source page: https://510kreport.com/device/K993194
Methodology: https://510kreport.com/methodology