Cleared Traditional

HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. (K890864) - FDA 510(k) Clearance

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

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

Submission Details

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
31d slower than avg
Panel avg: 89d · This submission: 120d
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.