Cleared Traditional

K890864 - HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.

K890864 is an FDA 510(k) clearance for HANDTYMP SCREENER MODEL 2000 + 2002 REM..., manufactured by Rastronics USA, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K890864 · Rastronics USA, Inc. · Ear, Nose, Throat device
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Jun 1989
Decision
120d
Days
Class 2
Risk

K890864 is an FDA 510(k) clearance for the HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Rastronics USA, Inc. (Bensenville, US). The FDA issued a Cleared decision on June 21, 1989 after a review of 120 days - within the typical 510(k) review window.

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: 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 Rastronics USA, Inc. devices

FDA 510(k) Submission Details - K890864

510(k) Number K890864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date June 21, 1989
Days to Decision 120 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
30d slower than avg
Panel avg: 90d · This submission: 120d
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 46
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K890864.
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · American Electromedics Corp. · Feb 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · American Electromedics Corp. · Feb 1991
AE-105D DIAGNOSTIC TYMPANOMETER
K894260 · American Electromedics Corp. · Jan 1990
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
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