Cleared Traditional

K853004 - PORTABLE OXYGEN UNIT

K853004 is an FDA 510(k) clearance for PORTABLE OXYGEN UNIT, manufactured by B & F Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K853004 · B & F Medical Products, Inc. · Anesthesiology device
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Aug 1985
Decision
44d
Days
Class 2
Risk

K853004 is an FDA 510(k) clearance for the PORTABLE OXYGEN UNIT. 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 B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 44 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 B & F Medical Products, Inc. devices

FDA 510(k) Submission Details - K853004

510(k) Number K853004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1985
Decision Date August 29, 1985
Days to Decision 44 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
96d faster than avg
Panel avg: 140d · This submission: 44d
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 K853004.
BUNN LITE OXYGEN CONCENTRATOR
K855208 · The John Bunn Co. · Feb 1986
RX02 PLUS OXYGEN CONCENTRATOR
K860060 · The John Bunn Co. · Feb 1986
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374 · Healthdyne, Inc. · Jan 1986
SIERRA -OXYGEN CONCENTRATE
K852144 · Mountain Medical Equipment, Inc. · Aug 1985
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · Invacare Corp. · Jul 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435 · Invacare Corp. · Jul 1985