Cleared Traditional

K923660 - MEDISONIC OXYGEN FLOW CONTROLLER

K923660 is an FDA 510(k) clearance for MEDISONIC OXYGEN FLOW CONTROLLER, manufactured by Medisonic U.S.A., Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K923660 · Medisonic U.S.A., Inc. · Anesthesiology device
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Jan 1993
Decision
189d
Days
Class 2
Risk

K923660 is an FDA 510(k) clearance for the MEDISONIC OXYGEN FLOW CONTROLLER. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Medisonic U.S.A., Inc. (Clarence, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 189 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 Medisonic U.S.A., Inc. devices

FDA 510(k) Submission Details - K923660

510(k) Number K923660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1992
Decision Date January 27, 1993
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
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 55
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K923660.
AIRSEP IMPULSE
K962766 · Airsep Corp. · Oct 1996
OXYPULSE EOC I, EOC II & EOC R
K955129 · Eagle Medical Equipment Co. · Feb 1996
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · Salter Labs · Jul 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · Devilbiss Health Care, Inc. · Apr 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · Salter Labs · Feb 1989