Cleared Traditional

K910316 - OHMEDA - LOW FLOW FLOWMETER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K910316 · Ohmeda Medical · Anesthesiology device
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Apr 1991
Decision
78d
Days
Class 1
Risk

K910316 is an FDA 510(k) clearance for the OHMEDA - LOW FLOW FLOWMETER. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2340 - 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 Ohmeda Medical devices

Submission Details

510(k) Number K910316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1991
Decision Date April 12, 1991
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 139d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.