Cleared Traditional

K923830 - XOMED-TREACE ALPHASCOPE

K923830 is an FDA 510(k) clearance for XOMED-TREACE ALPHASCOPE, manufactured by Xomed-Treace, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K923830 · Xomed-Treace, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
101d
Days
Class 1
Risk

K923830 is an FDA 510(k) clearance for the XOMED-TREACE ALPHASCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Xomed-Treace, Inc. devices

FDA 510(k) Submission Details - K923830

510(k) Number K923830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1992
Decision Date November 09, 1992
Days to Decision 101 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
11d slower than avg
Panel avg: 90d · This submission: 101d
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 37
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K923830.
RI-SCOPE (S)
K932506 · Rudolf Riester GmbH & Co. KG · Oct 1993
OTOSCOPE
K925758 · Rudolf Riester GmbH & Co. KG · Aug 1993
UNI I
K925759 · Rudolf Riester GmbH & Co. KG · Jul 1993
OTO-BRITE HANDLE
K924025 · Jedmed Instrument Co. · Nov 1992
STARKEY LABORATORIES OTOSCOPE
K922752 · Starkey Laboratories, Inc. · Sep 1992
VIDEO OTOSCOPE
K904802 · Jedmed Instrument Co. · Jan 1991