Cleared Traditional

K830173 - BERA SH 221 BRIAN STEM AUDIOMETER (FDA 510(k) Clearance)

Class I Microbiology device.

K830173 · Jedmed Instrument Co. · Microbiology device
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May 1983
Decision
127d
Days
Class 1
Risk

K830173 is an FDA 510(k) clearance for the BERA SH 221 BRIAN STEM AUDIOMETER. Classified as Antigens, Ha, Echovirus 1-34 (product code GNJ), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3205 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K830173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date May 25, 1983
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 102d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNJ Antigens, Ha, Echovirus 1-34
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3205
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.