Cleared Traditional

K843355 - TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K843355 · Kontron Instruments, Inc. · Neurology device
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Dec 1984
Decision
98d
Days
Class 3
Risk

K843355 is an FDA 510(k) clearance for the TRANSDUCER FOR KONTROL 5MHZ SIGMA 20. Classified as Stimulator, Vestibular Acceleration, Therapeutic (product code MHZ), Class III - Premarket Approval.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kontron Instruments, Inc. devices

Submission Details

510(k) Number K843355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date December 03, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MHZ Stimulator, Vestibular Acceleration, Therapeutic
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.