Cleared Traditional

K920842 - AEROSOL DELIVERY SYSTEMS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K920842 · Hospitak, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
81d
Days
Class 1
Risk

K920842 is an FDA 510(k) clearance for the AEROSOL DELIVERY SYSTEMS. Classified as Applicator, Ent Drug (product code LRD), Class I - General Controls.

Submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - the FDA ear, nose and throat 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 Hospitak, Inc. devices

Submission Details

510(k) Number K920842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date May 15, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 89d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRD Applicator, Ent Drug
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.