Cleared Traditional

K850644 - NASOPHARYNGEAL AIRWAY-ROBERTAZZI

K850644 is an FDA 510(k) clearance for NASOPHARYNGEAL AIRWAY-ROBERTAZZI, manufactured by Dryden Corp.. The device is a Class 1 Anesthesiology device with product code BTQ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K850644 · Dryden Corp. · Anesthesiology device
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Mar 1985
Decision
30d
Days
Class 1
Risk

K850644 is an FDA 510(k) clearance for the NASOPHARYNGEAL AIRWAY-ROBERTAZZI. Classified as Airway, Nasopharyngeal (product code BTQ), Class I - General Controls.

Submitted by Dryden Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 30 days - a notably fast clearance 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: 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 Dryden Corp. devices

FDA 510(k) Submission Details - K850644

510(k) Number K850644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date March 21, 1985
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
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 K850644.
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
LINDER NASOPHARYNGEAL AIRWAY
K843524 · Polamedco, Inc. · Oct 1984
NASOPHARYNGEAL AIRWAYS
K841093 · Inmed Corp. · Mar 1984
AIRWAYS & NASOPHARYNGEAL TYPE
K830983 · Medovations, Inc. · May 1983