# K963177: TED 191

- Pathway: 510(k) (Traditional)
- Applicant: Teledyne Brown Engineering
- Decided: Nov 13, 1997 after 456 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- 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 Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas). The device is primarily intended for use in medical applications such as oxygen therapy and ventilatory monjtoring, although it may be used in ancillary applications such as checking the purity of compressed air and oxygen, or mixes thereof.

Source page: https://510kreport.com/device/K963177
Methodology: https://510kreport.com/methodology