Cleared Traditional

K924146 - OH-500 OXYGEN CONCENTRATOR

K924146 is an FDA 510(k) clearance for OH-500 OXYGEN CONCENTRATOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K924146 · Healthdyne, Inc. · Anesthesiology device
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Jan 1993
Decision
142d
Days
Class 2
Risk

K924146 is an FDA 510(k) clearance for the OH-500 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 January 7, 1993 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthdyne, Inc. devices

FDA 510(k) Submission Details - K924146

510(k) Number K924146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date January 07, 1993
Days to Decision 142 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 140d · This submission: 142d
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 132
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K924146.
KEYSTONE CONCENTRATOR, MODEL PV5L
K924152 · Devilbiss Health Care, Inc. · Jun 1993
OXYGEN CONCENTRATOR
K924100 · Allied Healthcare Products, Inc. · Mar 1993
SCOTTY
K923650 · Mountain Medical Equipment, Inc. · Jan 1993
ALPINE V
K914916 · Mountain Medical Equipment, Inc. · Sep 1992
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488 · Invacare Corp. · Sep 1992
PORTABLE OXYGEN GENERATOR
K915381 · Aequitron Medical, Inc. · Mar 1992