Cleared Traditional

K854374 - OXYGEN CONCENTRATOR

K854374 is the FDA 510(k) clearance for OXYGEN CONCENTRATOR by Healthdyne, Inc.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K854374 · Healthdyne, Inc. · Anesthesiology device
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Jan 1986
Decision
65d
Days
Class 2
Risk

K854374 is an FDA 510(k) clearance for the OXYGEN CONCENTRATOR, MODEL BX-5000. 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 Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 65 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.

View all Healthdyne, Inc. devices

Submission Details

510(k) Number K854374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1985
Decision Date January 03, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 67
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K854374.
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · Puritan Bennett Corp. · Nov 1989
MODEL 590 OXYGEN CONCENTRATOR
K895141 · Puritan Bennett Corp. · Oct 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488 · Invacare Corp. · May 1989
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · Invacare Corp. · Jul 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435 · Invacare Corp. · Jul 1985
PRIME AIRE O2 PLUS 2
K851437 · Invacare Corp. · Jul 1985