Cleared Traditional

K863613 - NO-FLO I (FDA 510(k) Clearance)

Class I Anesthesiology device.

K863613 · Design Technologies, Inc. · Anesthesiology device
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Dec 1986
Decision
90d
Days
Class 1
Risk

K863613 is an FDA 510(k) clearance for the NO-FLO I. Classified as Flowmeter, Nonback-pressure Compensated, Bourdon Gauge (product code CCN), Class I - General Controls.

Submitted by Design Technologies, Inc. (Rahway, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Design Technologies, Inc. devices

Submission Details

510(k) Number K863613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date December 15, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 139d · This submission: 90d
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.