Cleared Traditional

K940320 - AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K940320 · Ad-Tech Medical Instrument Corp · Anesthesiology device
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Sep 1995
Decision
603d
Days
Class 1
Risk

K940320 is an FDA 510(k) clearance for the AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS. Classified as Airway, Nasopharyngeal (product code BTQ), Class I - General Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 603 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Ad-Tech Medical Instrument Corp devices

Submission Details

510(k) Number K940320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1994
Decision Date September 19, 1995
Days to Decision 603 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
464d slower than avg
Panel avg: 139d · This submission: 603d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTQ Airway, Nasopharyngeal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5100
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.