Cleared Traditional

K953732 - TECA PREMIERE

K953732 is an FDA 510(k) clearance for TECA PREMIERE, manufactured by Medelec , Ltd.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K953732 · Medelec , Ltd. · Neurology device
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Oct 1995
Decision
80d
Days
Class 2
Risk

K953732 is an FDA 510(k) clearance for the TECA PREMIERE. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Medelec , Ltd. (Old Woking, Surrey, DE). The FDA issued a Cleared decision on October 19, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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 Medelec , Ltd. devices

FDA 510(k) Submission Details - K953732

510(k) Number K953732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date October 19, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 37
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K953732.
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