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Deployable Oxygen Concentration System (DOCS)

by Pacific Consolidated Industries Llp United States 510(k)

510(k) K020330 Product code CAW

Overview

The Deployable Oxygen Concentration System (DOCS) is a portable oxygen generator designed to produce oxygen on-site. It is classified as a Class II medical device under regulation number 868.5440 and has been determined to be substantially equivalent through the FDA 510(k) clearance process (K020330).

The device is intended for use in medical settings where oxygen generation is required, as indicated by its assignment to the Anesthesiology medical specialty. It is supplied as a reusable system and is not described as sterile or single-use in the provided data. No information regarding MRI safety, specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance is included in the device data.

Summary written by AI from registry data, 24 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK020330 Date12 Apr 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
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  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Deployable Oxygen Concentration System (DOCS) intended for?

    The DOCS is intended for use in medical settings where oxygen generation is required, specifically within the anesthesiology specialty, as it generates oxygen on-site for clinical use.

  • Is the Deployable Oxygen Concentration System (DOCS) reusable or single-use?

    The DOCS is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, and is not described as single-use or sterile in the provided data.

  • What regulatory pathway was used for the Deployable Oxygen Concentration System (DOCS)?

    The DOCS received FDA 510(k) clearance under K020330, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under regulation 868.5440.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K020330 24 fields · synced 22 Oct 2026