Cleared Traditional

K850560 - FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K850560 · Precision Medical, Inc. · Anesthesiology device
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Apr 1985
Decision
64d
Days
Class 1
Risk

K850560 is an FDA 510(k) clearance for the FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Precision Medical, Inc. (Bath, US). The FDA issued a Cleared decision on April 17, 1985 after a review of 64 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 Precision Medical, Inc. devices

Submission Details

510(k) Number K850560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1985
Decision Date April 17, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 139d · This submission: 64d
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.