# K961150: Dual Lumen Oxygen Delivery Gas Sampling Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: Sep 10, 1996 after 172 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: 1 generation back to K863883 (1986). 2 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892406: Modified Oxygen Delivery/CO2 Sample Nasal Cannula, Salter Labs (1989) Summary page 1.
- K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula, Salter Labs (1986) Summary page 1.

## Most influential descendants
- K123176: Iso-Gard Clearair Mask (2013), 2 descendants of its own
- K132946: Softech Plus ETC02 Cannula (2014), 1 descendant of its own
- K132729: Iso-Gard Mask (2014), 1 descendant of its own
- K161250: OC-FLEX Flexible IntraOral Cannula (2017), 0 descendants of its own
- K143469: SOFTECH Plus ETCO2 Cannula (2015), 0 descendants of its own

## Indications for use
The Hudson RCI Gas Sampling Oxygen 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/K961150
Methodology: https://510kreport.com/methodology