Cleared Traditional

K040738 - MOBILE OXYGEN STORAGE TANK (MOST)

K040738 is an FDA 510(k) clearance for MOBILE OXYGEN STORAGE TANK (MOST), manufactured by Pacific Consolidated Industries Llp. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K040738 · Pacific Consolidated Industries Llp · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
39d
Days
Class 2
Risk

K040738 is an FDA 510(k) clearance for the MOBILE OXYGEN STORAGE TANK (MOST). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Pacific Consolidated Industries Llp (Santa Ana, US). The FDA issued a Cleared decision on April 30, 2004 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040738

510(k) Number K040738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2004
Decision Date April 30, 2004
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 140d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 282
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K040738.
INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
K042262 · Sequal Technologies, Inc. · Sep 2004
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
K041664 · On Site Gas Systems, Inc. · Jul 2004
INOGEN ONE OXYGEN CONCENTRATOR
K032818 · Inogen, Inc. · May 2004
MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
K040892 · Nidek Medical Products, Inc. · Apr 2004
MARK 5 NUVO (M5C5)
K032509 · Nidek Medical Products, Inc. · Mar 2004
POGS 33
K030920 · On Site Gas Systems, Inc. · Mar 2004
K040738 · MOBILE OXYGEN STORAGE TANK (MOST)
Download PDF FDA Summary Pacific Consolidated …