Cleared Traditional

K941659 - AURAL-CAM

K941659 is an FDA 510(k) clearance for AURAL-CAM, manufactured by Gracefully Yours, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K941659 · Gracefully Yours, Inc. · Ear, Nose, Throat device
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Apr 1994
Decision
21d
Days
Class 1
Risk

K941659 is an FDA 510(k) clearance for the AURAL-CAM, VIDEO EAR, VID RX. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Gracefully Yours, Inc. (Largo, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 21 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 Gracefully Yours, Inc. devices

FDA 510(k) Submission Details - K941659

510(k) Number K941659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date April 26, 1994
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

ERA Device Classification - Class 1, General Controls

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.

Regulatory Peers - ERA Otoscope

All 30
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K941659.
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · Smith & Nephew, Inc. · Nov 1994
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031 · Jedmed Instrument Co. · Sep 1994
VIDEOTOSCOPE
K943916 · Welch Allyn, Inc. · Aug 1994
STANDARD
K925752 · Rudolf Riester GmbH & Co. KG · Oct 1993
UNI III
K925753 · Rudolf Riester GmbH & Co. KG · Oct 1993
RI-MINI
K932503 · Rudolf Riester GmbH & Co. KG · Oct 1993