Cleared Traditional

K810314 - WILLIAM HARVEY FLOWMETER SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K810314 · C.R. Bard, Inc. · Anesthesiology device
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Feb 1981
Decision
14d
Days
Class 1
Risk

K810314 is an FDA 510(k) clearance for the WILLIAM HARVEY FLOWMETER SYSTEM. Classified as Tube, Thorpe, Uncompensated (product code BYM), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2320 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K810314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date February 19, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 139d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYM Tube, Thorpe, Uncompensated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2320
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.