Cleared Traditional

K871262 - MODIFIED NOFLO I

K871262 is an FDA 510(k) clearance for MODIFIED NOFLO 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 112-day FDA review.

K871262 · Design Technologies, Inc. · Anesthesiology device
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Jul 1987
Decision
112d
Days
Class 1
Risk

K871262 is an FDA 510(k) clearance for the MODIFIED NOFLO 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 July 21, 1987 after a review of 112 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 - K871262

510(k) Number K871262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date July 21, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
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

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