# K963042: Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853

- Pathway: 510(k) (Traditional)
- Applicant: Sim Italia S.R.L.
- Decided: Nov 1, 1996 after 88 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- 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 K933081 (1994). 3 ancestors in all.
42 later devices descend from it; 3 cite it directly.
4 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933081: Oxlife Oxygen Concentrator, Oxlife, Inc. (1994) Summary page 1.
- K955549: Oxlife Oxygen Concentrators, Oxlife, Inc. (1996) Summary page 1.
- K852650: Oxymatictm Electronic Oxgyen Conserver, Chad Therapeutics, Inc. (1985). Our OCR of the scanned summary read K952650, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Chad Therapeutics Oxymatic™ Electronic Oxygen Conserver”.

## Most influential descendants
- K013931: Omni Oxygen System, Model 1000 (2002), 38 descendants of its own
- K083163: Omni 2 Oxygen System (2009), 18 descendants of its own
- K120785: Omni 3 Oxygen System (2012), 9 descendants of its own
- K093261: MOVES (2010), 7 descendants of its own
- K162877: VOCSN Unified Respiratory System (2017), 6 descendants of its own

## Indications for use
The Innosan Travelair® "S" Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile’s battery, intended to provide a patient with supplemental oxygen.

Source page: https://510kreport.com/device/K963042
Methodology: https://510kreport.com/methodology