Cleared Traditional

K812715 - TECA #TE 8

K812715 is an FDA 510(k) clearance for TECA #TE 8, manufactured by Teca, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812715 · Teca, Inc. · Neurology device
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Oct 1981
Decision
18d
Days
Class 2
Risk

K812715 is an FDA 510(k) clearance for the TECA #TE 8. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Teca, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 Teca, Inc. devices

FDA 510(k) Submission Details - K812715

510(k) Number K812715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1981
Decision Date October 13, 1981
Days to Decision 18 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
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 16
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K812715.
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ANESTHESIA & BRAIN MONITOR
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TECA MODEL-10 ELECTROMYOGRAPH
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CADWELL 7000 ELECTROMYOGRAPH MACHINE
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