Cleared Traditional

K843691 - PORTABLE OXYGEN UNIT

K843691 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 49-day FDA review.

K843691 · B & F Medical Products, Inc. · Anesthesiology device
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Nov 1984
Decision
49d
Days
Class 2
Risk

K843691 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 November 7, 1984 after a review of 49 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 - K843691

510(k) Number K843691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1984
Decision Date November 07, 1984
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
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 133
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K843691.
ECONO MATE -OXYGEN CONCENTRATOR
K850253 · Mountain Medical Equipment, Inc. · Feb 1985
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · Everest & Jennings, Inc. · Dec 1984
OXYGEN CONCENTRATOR
K844328 · Hospitak, Inc. · Dec 1984
ECONO MATE
K843715 · Mountain Medical Equipment, Inc. · Oct 1984
BUNN 3001 OXYGEN CONCENTRATOR
K843811 · The John Bunn Co. · Oct 1984
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · Puritan Bennett Corp. · Aug 1984