Cleared Traditional

K884973 - FR6000 FLOWMETER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K884973 · Key Instruments · Anesthesiology device
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Jan 1989
Decision
48d
Days
Class 1
Risk

K884973 is an FDA 510(k) clearance for the FR6000 FLOWMETER. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Key Instruments (Trevose, US). The FDA issued a Cleared decision on January 17, 1989 after a review of 48 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.

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Submission Details

510(k) Number K884973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date January 17, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 139d · This submission: 48d
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.