# K200496: Aer X

- Pathway: 510(k) (Special)
- Applicant: 3B Medical, Inc.
- Decided: Jul 24, 2020 after 147 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 K020324 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121260: Trooper Oxygen Concentrator, Vbox, Inc. (2012) Summary page 4.

## Indications for use
The Aer X oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Aer X may be used in home, institution, vehicle and various mobile environments.

Source page: https://510kreport.com/device/K200496
Methodology: https://510kreport.com/methodology