Cleared Traditional

K884870 - TECA/MEDELEC 'CONCEPT' P420

K884870 is an FDA 510(k) clearance for TECA/MEDELEC 'CONCEPT' P420, manufactured by Teca, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K884870 · Teca, Inc. · Neurology device
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Feb 1989
Decision
94d
Days
Class 2
Risk

K884870 is an FDA 510(k) clearance for the TECA/MEDELEC 'CONCEPT' P420. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 94 days - within the typical 510(k) review window.

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: 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 Teca, Inc. devices

FDA 510(k) Submission Details - K884870

510(k) Number K884870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date February 23, 1989
Days to Decision 94 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
54d faster than avg
Panel avg: 148d · This submission: 94d
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 54
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K884870.
HIGH SPEED MAGNETIC STIMULATOR
K905059 · Cadwell Laboratories, Inc. · Sep 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991
MEM-7102
K890274 · Nihon Kohden America, Inc. · May 1989
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc. · May 1988
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · Novametrix Medical Systems, Inc. · Aug 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · Cadwell Laboratories, Inc. · Jan 1987