# K051887: Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)

- Pathway: 510(k) (Traditional)
- Applicant: Carleton Life Support Systems, Inc.
- Decided: Sep 27, 2005 after 77 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: 1 generation back to K013223 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013223: Patient Ventilation Oxygen Concentrating System (Pvocs), Litton Systems, Inc. (2002) Summary page 1.

## Indications for use
The PVOCS HF system is intended to provide respiratory gases to include pre and post operation respiratory oxygen, pneumatic drive gas for ventilators, and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used in military field hospitals and other applications when oxygen stored in high pressure cylinders or liquid oxygen is not available, practical, or safe to use. It is appropriate for use by military personnel only.

Source page: https://510kreport.com/device/K051887
Methodology: https://510kreport.com/methodology