# K971947: Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory)

- Pathway: 510(k) (Traditional)
- Applicant: Sim Italia S.R.L.
- Decided: Oct 3, 1997 after 128 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: 3 generations back to K933081 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963042: Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853, Sim Italia S.R.L. (1996) Summary page 1.

## Most influential descendants
- K053230: Merits Health Products Oxygen Concentrators (2006), 0 descendants of its own
- K030233: Travelsome Standard (2003), 0 descendants of its own

## Indications for use
The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile’s battery or for use with a power supply accessory (off of a mains current - 110 VAC, 60 Hz or 220 VAC, 50 Hz) when the patient is away from their primary home oxygen source, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.

Source page: https://510kreport.com/device/K971947
Methodology: https://510kreport.com/methodology