# K043520: Emg CTA01-XXX Series Puro Oxygen Concentrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Emg Technology Co., Ltd.
- Decided: Oct 21, 2005 after 305 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 4, 2008 · Not classified · Z-1474-2008: Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.
- Mar 4, 2008 · Not classified · Z-1473-2008: Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.

## Indications for use
The EMG CTXO1-XXX Series Oxygen Concentrator is designed to provide I to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.

Source page: https://510kreport.com/device/K043520
Methodology: https://510kreport.com/methodology