# K100957: Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen Ceoncentration

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Consolidated Industries, LLC
- Decided: Jan 21, 2011 after 289 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: 7 generations back to K933081 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020330: Deployable Oxygen Concentration System (Docs), Pacific Consolidated Industries Llp (2002) Summary page 2.
- K061414: Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile Oxygen Storage Tank (Most), Mod, Pacific Consolidated Industries, LLC (2007) Summary page 2.

## Indications for use
The Deployable Oxygen Concentration System (DOCS) Family of devices generates and delivers USP grade 93% ± 3% oxygen. The oxygen supplied by these units is for supplemental use and is not considered to be life supporting or life sustaining. DOCS Family devices may be used to fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use. These devices are to be used only by trained personnel in disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available, as hospital backup systems, in local emergencies where disaster has rendered the primary oxygen supply unusable, or by trained military personnel in peacetime or wartime support of Armed Forces.

Source page: https://510kreport.com/device/K100957
Methodology: https://510kreport.com/methodology