Skip to content

EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM - Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B And 30

by Pacific Consolidated Industries LLC

510(k) K061414

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061414 Date22 Jan 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2201-2008 FDA Unclassified (pre-2012) initiated 8 Sep 2007

    The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges. With one unit the operator was able to shut off the oxygen flow, however one rupture resulted in a fire. No injuries were reported.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAW
Models / Variants
Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B And 30
FDA applicant
Pacific Consolidated Industries, LLC
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Pacific Consolidated Industries LLC

See all devices from Pacific Consolidated Industries LLC →