Cleared Traditional

K861325 - MAXI-USE O2 DEVICE

K861325 is an FDA 510(k) clearance for MAXI-USE O2 DEVICE, manufactured by B & F Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K861325 · B & F Medical Products, Inc. · Anesthesiology device
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Sep 1986
Decision
153d
Days
Class 2
Risk

K861325 is an FDA 510(k) clearance for the MAXI-USE O2 DEVICE. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 153 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 B & F Medical Products, Inc. devices

FDA 510(k) Submission Details - K861325

510(k) Number K861325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1986
Decision Date September 09, 1986
Days to Decision 153 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
13d slower than avg
Panel avg: 140d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 33
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K861325.
BUNN MODEL 50 OXYGEN FLOW CONTROLLER
K883216 · The John Bunn Co. · Aug 1988
COMPANION MINI OXYGEN SAVER
K873901 · Puritan Bennett Corp. · Dec 1987
COMPANION OXYGEN SAVER
K863695 · Puritan Bennett Corp. · Oct 1986
BUNN MODEL 22 OXYGEN FLOW CONTROLLER
K861199 · The John Bunn Co. · Aug 1986
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
K852650 · Chad Therapeutics, Inc. · Aug 1985
OXYMIZER-PENDANT
K834588 · Chad Therapeutics, Inc. · Mar 1984