# K973066: Non-Rebreathing 'T' (BE 117)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Feb 3, 1998 after 169 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
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
This is a ‘T’ containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port. The reusable BE 117 Non-Rebreathing ‘T’ is designed for use with a spontaneously breathing patient where “back flow” must be avoided. The ‘T’s are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 ‘T’ is intended to be used with a spirometer.

Source page: https://510kreport.com/device/K973066
Methodology: https://510kreport.com/methodology