Cleared Traditional

K940320 - AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS

K940320 is an FDA 510(k) clearance for AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 1 Anesthesiology device with product code BTQ cleared through the Traditional 510(k) pathway after a 603-day FDA review.

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

FDA 510(k) Submission Details - K940320

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
463d slower than avg
Panel avg: 140d · This submission: 603d
Pathway characteristics
Predicate-based equivalence.

BTQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - BTQ Airway, Nasopharyngeal

All 8
Devices cleared under the same product code (BTQ) and FDA review panel - the closest regulatory comparables to K940320.
POLAMEDCO NASOPAHARYNGEAL AIRWAY
K900456 · Polamedco, Inc. · Apr 1990
SUNDERLAND NASAL TUBE
K883668 · Exmoor Plastics , Ltd. · Nov 1988
STERILE NASOPHARYNGEAL AIRWAY
K853162 · Inmed Corp. · Aug 1985
NASOPHARYNGEAL AIRWAY-ROBERTAZZI
K850644 · Dryden Corp. · Mar 1985
LINDER NASOPHARYNGEAL AIRWAY
K843524 · Polamedco, Inc. · Oct 1984
NASOPHARYNGEAL AIRWAYS
K841093 · Inmed Corp. · Mar 1984