Cleared Traditional

K903618 - ROBERTAZZI NASOPHARYNGEAL AIRWAY

K903618 is an FDA 510(k) clearance for ROBERTAZZI NASOPHARYNGEAL AIRWAY, manufactured by Eastmed Enterprises, Inc.. The device is a Class 1 Anesthesiology device with product code BTQ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K903618 · Eastmed Enterprises, Inc. · Anesthesiology device
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Jan 1991
Decision
154d
Days
Class 1
Risk

K903618 is an FDA 510(k) clearance for the ROBERTAZZI NASOPHARYNGEAL AIRWAY. Classified as Airway, Nasopharyngeal (product code BTQ), Class I - General Controls.

Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on January 8, 1991 after a review of 154 days - an extended review cycle.

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: 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 Eastmed Enterprises, Inc. devices

FDA 510(k) Submission Details - K903618

510(k) Number K903618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date January 08, 1991
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 9
Devices cleared under the same product code (BTQ) and FDA review panel - the closest regulatory comparables to K903618.
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
K940320 · Ad-Tech Medical Instrument Corp · Sep 1995
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