# K101272: Mass Oxygen Distribution System (Mods) Model 10C-0061-3

- Pathway: 510(k) (Traditional)
- Applicant: Essex Industries, Inc.
- Decided: Aug 20, 2010 after 106 days
- Product code: BYJ (Unit, Liquid-Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5655
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880183 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033000: Next Generation Portable Therapeutic Liquid Oxygen System, Essex Cryogenics of Missouri, Inc. (2004) Summary page 1.

## Indications for use
The MODS is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery to a patient at one-half (0.5) to fifteen (15) LPM and fifty (50) psig.

Source page: https://510kreport.com/device/K101272
Methodology: https://510kreport.com/methodology