Cleared Traditional

K861069 - TECA NEUROPTO WITH OS-5 STIMULATOR

K861069 is an FDA 510(k) clearance for TECA NEUROPTO WITH OS-5 STIMULATOR, manufactured by Teca, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K861069 · Teca, Inc. · Neurology device
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Jan 1987
Decision
313d
Days
Class 2
Risk

K861069 is an FDA 510(k) clearance for the TECA NEUROPTO WITH OS-5 STIMULATOR. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on January 27, 1987 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K861069

510(k) Number K861069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1986
Decision Date January 27, 1987
Days to Decision 313 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
165d slower than avg
Panel avg: 148d · This submission: 313d
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
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K861069.
KILOWIN
K971214 · Cadwell Laboratories, Inc. · Jun 1998
TECA/MEDELEC MISTRAL
K880593 · Teca, Inc. · Apr 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136 · Bio-Logic Systems Corp. · Mar 1988
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · Cadwell Laboratories, Inc. · Nov 1986
MODIFIED BRAIN ATLAS III
K854362 · Bio-Logic Systems Corp. · Apr 1986
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · Bio-Logic Systems Corp. · Dec 1985