# K131016: ROGS

- Pathway: 510(k) (Special)
- Applicant: Molecular Products, Ltd.
- Decided: Nov 27, 2013 after 230 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: 4 generations back to K780020 (1978). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062153: Portable Oxygen Generator System, Molecular Products, Ltd. (2006) Summary page 1.

## Most influential descendants
- K240561: Rugged Oxygen Generator  (ROG) (RO01-00001) (2024), 0 descendants of its own

## Indications for use
Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).

Source page: https://510kreport.com/device/K131016
Methodology: https://510kreport.com/methodology