# K960240: Rusch Optosafe

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Apr 19, 1996 after 94 days
- Product code: CAE (Airway, Oropharyngeal, Anesthesiology)
- Device class: 1
- Regulation: 21 CFR 868.5110
- 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 K830767 (1983). 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)
- K830767: Williams Airway Intubator, Williams Airway Intubator (1983) Summary page 1.

## Indications for use
The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation.

Source page: https://510kreport.com/device/K960240
Methodology: https://510kreport.com/methodology