Cleared Traditional

K831047 - BIOLOGIC SYSTEM BL 101

K831047 is an FDA 510(k) clearance for BIOLOGIC SYSTEM BL 101, manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K831047 · Bio-Logic Systems Corp. · Neurology device
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May 1983
Decision
43d
Days
Class 2
Risk

K831047 is an FDA 510(k) clearance for the BIOLOGIC SYSTEM BL 101. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K831047

510(k) Number K831047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1983
Decision Date May 13, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 20
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