# K101286: Sedara Gas Mixer, Sedara Scavenger Model: 03, 04

- Pathway: 510(k) (Traditional)
- Applicant: Linde Healthcare AB
- Decided: Oct 20, 2011 after 531 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- 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 K790333 (1979). 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)
- K883833: Nitronox (R), First Response Nitronox (TM), Matrix Medica, Inc. (1989) Summary page 1.
- K080039: Passive Waste Gas Scavenger, Model 14600, G. Dundas Co.,Inc. (2008) Summary page 1.

## Indications for use
The SEDARA™ Gas Mixer System is indicated for mixing and delivering Nitrous Oxide (N2O) and oxygen (O2), in a ratio of 1:1, at a fixed concentration of 50%/50% (V/V), to spontaneously breathing patients of at least 15 kg body weight and four years of age, who have been examined by the attending physician prior to SEDARA™ System use and are under the continuous supervision of a healthcare professional in a clinical facility, such as a hospital, a free-standing ambulatory surgical center, or an outpatient clinic.

Source page: https://510kreport.com/device/K101286
Methodology: https://510kreport.com/methodology