Cleared Traditional

K830771 - CADWELL 8400

K830771 is an FDA 510(k) clearance for CADWELL 8400, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K830771 · Cadwell Laboratories, Inc. · Neurology device
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Apr 1983
Decision
32d
Days
Class 2
Risk

K830771 is an FDA 510(k) clearance for the CADWELL 8400. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K830771

510(k) Number K830771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1983
Decision Date April 12, 1983
Days to Decision 32 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
116d faster than avg
Panel avg: 148d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 61
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K830771.
QUANTUM 84
K844707 · Cadwell Laboratories, Inc. · May 1985
EVOKED POTENTIAL SYS
K842543 · Bio-Logic Systems Corp. · Nov 1984
COMPACT FOUR
K831896 · Nicolet Biomedical Instruments · Jul 1983
#ST10 PROGR. EVOKED RESPONSE STIMULATOR
K822744 · Teca, Inc. · Nov 1982
CADWELL 7400
K822214 · Cadwell Laboratories, Inc. · Sep 1982
TECA MODEL SENSOR ER 94
K820908 · Teca, Inc. · May 1982