Cleared Traditional

SPECULUM, ENT (S3) (K951050) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K951050 · Pedia Pals, Inc. · Ear, Nose, Throat device
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Apr 1995
Decision
42d
Days
Class 1
Risk

K951050 is an FDA 510(k) clearance for the SPECULUM, ENT (S3). Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Pedia Pals, Inc. (Columbus, US). The FDA issued a Cleared decision on April 17, 1995 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - 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 Pedia Pals, Inc. devices

Submission Details

510(k) Number K951050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date April 17, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 89d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
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.