Cleared Traditional

K872038 - NEB-U-VENT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K872038 · Design Technologies, Inc. · Anesthesiology device
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Aug 1987
Decision
75d
Days
Class 1
Risk

K872038 is an FDA 510(k) clearance for the NEB-U-VENT. 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 August 10, 1987 after a review of 75 days - a notably fast clearance cycle.

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: 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 Design Technologies, Inc. devices

Submission Details

510(k) Number K872038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date August 10, 1987
Days to Decision 75 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 139d · This submission: 75d
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.