# K030233: Travelsome Standard

- Pathway: 510(k) (Special)
- Applicant: Sim Italia S.R.L.
- Decided: Apr 25, 2003 after 92 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: 4 generations back to K933081 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971947: Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory), Sim Italia S.R.L. (1997) Summary page 1.
- K963042: Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853, Sim Italia S.R.L. (1996) Summary page 1.

## Indications for use
The TravelSome Standard Portable Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home, or during travel by car.

Source page: https://510kreport.com/device/K030233
Methodology: https://510kreport.com/methodology