Cleared Traditional

K922488 - PHASIS ELECTROMYOGRAPH

K922488 is an FDA 510(k) clearance for PHASIS ELECTROMYOGRAPH, manufactured by Biosound, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K922488 · Biosound, Inc. · Neurology device
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Mar 1993
Decision
279d
Days
Class 2
Risk

K922488 is an FDA 510(k) clearance for the PHASIS ELECTROMYOGRAPH. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Biosound, Inc. (San Jose, US). The FDA issued a Cleared decision on March 2, 1993 after a review of 279 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosound, Inc. devices

FDA 510(k) Submission Details - K922488

510(k) Number K922488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date March 02, 1993
Days to Decision 279 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 148d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Neurology devices follow this clearance model.

Regulatory Peers - IKN Electromyograph, Diagnostic

All 16
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K922488.
TOENNIES NEUROSCREEN SYSTEM
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NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · Bio-Logic Systems Corp. · Jul 1993
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983