Cleared Traditional

K863613 - NO-FLO I

K863613 is an FDA 510(k) clearance for NO-FLO I, manufactured by Design Technologies, Inc.. The device is a Class 1 Anesthesiology device with product code CCN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K863613

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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

CCN Device Classification - Class 1, General Controls

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.

Regulatory Peers - CCN Flowmeter, Nonback-pressure Compensated, Bourdon Gauge

Devices cleared under the same product code (CCN) and FDA review panel - the closest regulatory comparables to K863613.
OXYGEN FLOW CONTROLLER
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K802037 · Corning Medical & Scientific · Nov 1980