Cleared Traditional

K771479 - NITROX 30 - ANESTHETIC GAS PROPORTIONER

K771479 is the FDA 510(k) clearance for NITROX 30 - ANESTHETIC GAS PROPORTIONER by Ohio Medical Products. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K771479 · Ohio Medical Products · Anesthesiology device
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Nov 1977
Decision
95d
Days
Class 2
Risk

K771479 is an FDA 510(k) clearance for the NITROX 30 - ANESTHETIC GAS PROPORTIONER. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on November 7, 1977 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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.

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Submission Details

510(k) Number K771479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date November 07, 1977
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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.