Cleared Traditional

K850007 - ACOUSTIC OTOCOPE RECORDER

K850007 is an FDA 510(k) clearance for ACOUSTIC OTOCOPE RECORDER, manufactured by Endeco Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K850007 · Endeco Medical, Inc. · Ear, Nose, Throat device
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Mar 1985
Decision
58d
Days
Class 2
Risk

K850007 is an FDA 510(k) clearance for the ACOUSTIC OTOCOPE RECORDER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Endeco Medical, Inc. (Marion, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 58 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 Endeco Medical, Inc. devices

FDA 510(k) Submission Details - K850007

510(k) Number K850007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1985
Decision Date March 01, 1985
Days to Decision 58 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
31d faster than avg
Panel avg: 89d · This submission: 58d
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 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K850007.
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · Maico Hearing Instruments, Inc. · Apr 1991
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · Maico Hearing Instruments, Inc. · Jul 1984
MA 610-IMPEDANCE AUDIOMETER
K831754 · Maico Hearing Instruments, Inc. · Jul 1983
MA600-IMPEDANCE AUDIOMETER
K831755 · Maico Hearing Instruments, Inc. · Jul 1983