Cleared Traditional

EXTERNAL NASAL SPLINT (K942724) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K942724 · Micromed Development Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
29d
Days
Class 1
Risk

K942724 is an FDA 510(k) clearance for the EXTERNAL NASAL SPLINT. Classified as Splint, Nasal (product code EPP), Class I - General Controls.

Submitted by Micromed Development Corp. (Clearwater, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5800 - 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 Micromed Development Corp. devices

Submission Details

510(k) Number K942724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1994
Decision Date July 08, 1994
Days to Decision 29 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
60d faster than avg
Panel avg: 89d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPP Splint, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5800
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.