Cleared Traditional

K942357 - H-500 ALLIANCE OXYGEN CONCENTRATOR

K942357 is the FDA 510(k) clearance for H-500 ALLIANCE OXYGEN CONCENTRATOR by Healthdyne, Inc.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K942357 · Healthdyne, Inc. · Anesthesiology device
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May 1994
Decision
10d
Days
Class 2
Risk

K942357 is an FDA 510(k) clearance for the H-500 ALLIANCE OXYGEN CONCENTRATOR. 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 May 27, 1994 after a review of 10 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 K942357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date May 27, 1994
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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
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