# K102750: O2-in-a-Box, O2-in-a-Box

- Pathway: 510(k) (Traditional)
- Applicant: Geto2, Inc.
- Decided: Feb 11, 2011 after 141 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 K780020 (1978). 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)
- K052396: Oxysure Portable Oxygen Generator, Model 615, Oxysure Systems, Inc. (2005) Summary page 1.
- K043615: Oxytec, Model 900, Oxytec Medical Corporation (2005) Summary page 4.

## Indications for use
Intended to produce oxygen for emergency use. There is a m1inimumli 6 LPM flow rate for at least 15 minutes established a mninimIum total oxygen capacity of 90 liters. Environment of use - locations where emergency oxygen maybe needed A portable oxygen generator intended to produce oxygn to provide su~pplemental oxygen as prescribed by a physician. Flow rate Delivery Time Total Oxygen Capacity 0.5 LPM. 60 mfinutes 30 liters 3 LP'M 30 minutes 90 liters Environment of use - Home, institutional, travel / mobile environments

Source page: https://510kreport.com/device/K102750
Methodology: https://510kreport.com/methodology