# K143469: SOFTECH Plus ETCO2 Cannula

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Feb 12, 2015 after 69 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K863883 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132946: Softech Plus ETC02 Cannula, Teleflexmedical, Inc. (2014) Summary page 4.

## Indications for use
The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.

Source page: https://510kreport.com/device/K143469
Methodology: https://510kreport.com/methodology