Cleared Traditional

INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER (K990652) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990652 · Idem (Int'L Dist. of Electronics For Medicine) · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
77d
Days
Class 2
Risk

K990652 is an FDA 510(k) clearance for the INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Idem (Int'L Dist. of Electronics For Medicine) (Benicia, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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 Idem (Int'L Dist. of Electronics For Medicine) devices

Submission Details

510(k) Number K990652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date May 17, 1999
Days to Decision 77 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
12d faster than avg
Panel avg: 89d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.