# K981047: Fresh Air

- Pathway: 510(k) (Traditional)
- Applicant: Colorado Medtech, Inc.
- Decided: Sep 16, 1999 after 545 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- 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
Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.

Source page: https://510kreport.com/device/K981047
Methodology: https://510kreport.com/methodology