Cleared Traditional

K860262 - TA-6C - PART NUMBER SLZ 7520

K860262 is an FDA 510(k) clearance for TA-6C - PART NUMBER SLZ 7520, manufactured by Teledyne Avionics Div. of Teledyne. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K860262 · Teledyne Avionics Div. of Teledyne · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
89d
Days
Class 2
Risk

K860262 is an FDA 510(k) clearance for the TA-6C - PART NUMBER SLZ 7520. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Teledyne Avionics Div. of Teledyne (Charlottesville, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 89 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.

FDA 510(k) Submission Details - K860262

510(k) Number K860262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1986
Decision Date April 23, 1986
Days to Decision 89 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 90d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ETY Tester, Auditory Impedance

All 55
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K860262.
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K883728 · American Electromedics Corp. · Jan 1989
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
K874354 · Madsen Electronics (Canada) , Ltd. · Jan 1988
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
Z0174, IMPEDANCE AUDIOMETER
K845049 · Madsen Electronics (Canada) , Ltd. · May 1985
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · Maico Hearing Instruments, Inc. · Jul 1984
CLINICAL TYMPANOMETER
K833045 · American Electromedics Corp. · Dec 1983
K860262 · TA-6C - PART NUMBER SLZ 7520
Download PDF Teledyne Avionics Div…