Cleared Traditional

K903618 - ROBERTAZZI NASOPHARYNGEAL AIRWAY (FDA 510(k) Clearance)

Class I Anesthesiology device.

K903618 · Eastmed Enterprises, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
15d slower than avg
Panel avg: 139d · This submission: 154d
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.