Cleared Traditional

K934945 - FLOWMETER NIPPLE ADAPTOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K934945 · Cardio-Search , Ltd. · Anesthesiology device
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Nov 1993
Decision
35d
Days
Class 1
Risk

K934945 is an FDA 510(k) clearance for the FLOWMETER NIPPLE ADAPTOR. Classified as Flowmeter, Nonback-pressure Compensated, Bourdon Gauge (product code CCN), Class I - General Controls.

Submitted by Cardio-Search , Ltd. (Dundas, Ont.L9h 5y2, Canada, CA). The FDA issued a Cleared decision on November 17, 1993 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2300 - 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 Cardio-Search , Ltd. devices

Submission Details

510(k) Number K934945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1993
Decision Date November 17, 1993
Days to Decision 35 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
104d faster than avg
Panel avg: 139d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCN Flowmeter, Nonback-pressure Compensated, Bourdon Gauge
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2300
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.