# K993528: Rusch Emergency Mask

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: May 31, 2000 after 226 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- 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 K933048 (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)
- K933048: Laerdal (TM) Pocket Mask, Modification, Laerdal Medical Corp. (1993) Summary page 1.

## Indications for use
The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support(inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The device is intended for mouth to mask ventilation by trained individuals trained in the use of the device and qualified to use the device. The device is intended to be used on adult,child and infant population.

Source page: https://510kreport.com/device/K993528
Methodology: https://510kreport.com/methodology