# K134023: 2300 Series Mgo Portable Oxygen

- Pathway: 510(k) (Traditional)
- Applicant: Ultra Electronics Limited Precision Air & Land SY
- Decided: Apr 25, 2014 after 116 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: 5 generations back to K933081 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081468: Devilbiss Portable Oxygen Concentrator, 306 Series, Sunrise Medical (2008) Summary page 3.
- K083163: Omni 2 Oxygen System, Sequal Technologies, Inc. (2009) Summary page 1.

## Indications for use
The 2300 Series mGO Portable Oxygen Generator is 1-3 L/min continuous flow (1-6 L/min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based on molecular sieve technology. The patient typically receives the oxygen through a nasal cannula. The device is not intended for life support, nor does it provide any patient monitoring capabilities. The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief. A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow settings should be adjusted only under the direction of a Physician. WARNING: Federal Law restricts this device to sale by or on order of a Physician

Source page: https://510kreport.com/device/K134023
Methodology: https://510kreport.com/methodology