# K132946: Softech Plus ETC02 Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 4, 2014 after 258 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: 2 generations back to K863883 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961150: Dual Lumen Oxygen Delivery Gas Sampling Cannula, Hudson Respiratory Care, Inc. (1996) Summary page 1.

## Most influential descendants
- K143469: SOFTECH Plus ETCO2 Cannula (2015), 0 descendants of its own

## Indications for use
The Hudson RCI SOFTECHO 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. Patient Population: Infant, Pediatric, Adult

Source page: https://510kreport.com/device/K132946
Methodology: https://510kreport.com/methodology