# K240561: Rugged Oxygen Generator  (ROG) (RO01-00001)

- Pathway: 510(k) (Traditional)
- Applicant: Molecular Products, Ltd.
- Decided: Dec 6, 2024 after 281 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 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)
- K131016: ROGS, Molecular Products, Ltd. (2013) Summary page 4.

## Indications for use
Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.

Source page: https://510kreport.com/device/K240561
Methodology: https://510kreport.com/methodology