Cleared Traditional

K854374 - OXYGEN CONCENTRATOR, MODEL BX-5000

K854374 is an FDA 510(k) clearance for 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 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

FDA 510(k) Submission Details - K854374

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
Combination Product No
PCCP Authorized No
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.

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 K854374.
SILENT PARTNER MODEL 10-1001
K861012 · Medical Devices, Inc. · Apr 1986
BUNN LITE OXYGEN CONCENTRATOR
K855208 · The John Bunn Co. · Feb 1986
RX02 PLUS OXYGEN CONCENTRATOR
K860060 · The John Bunn Co. · Feb 1986
PORTABLE OXYGEN UNIT
K853004 · B & F Medical Products, Inc. · Aug 1985
SIERRA -OXYGEN CONCENTRATE
K852144 · Mountain Medical Equipment, Inc. · Aug 1985
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · Invacare Corp. · Jul 1985