Cleared Traditional

K802637 - TECA MODEL-10 ELECTROMYOGRAPH

K802637 is an FDA 510(k) clearance for TECA MODEL-10 ELECTROMYOGRAPH, 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 35-day FDA review.

K802637 · Teca, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1980
Decision
35d
Days
Class 2
Risk

K802637 is an FDA 510(k) clearance for the TECA MODEL-10 ELECTROMYOGRAPH. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Teca, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 26, 1980 after a review of 35 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 - K802637

510(k) Number K802637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1980
Decision Date November 26, 1980
Days to Decision 35 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
113d faster than avg
Panel avg: 148d · This submission: 35d
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 K802637.
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624 · Del Mar Avionics · Oct 1982
ANESTHESIA & BRAIN MONITOR
K821910 · Datex Division Instrumentarium Corp. · Sep 1982
TECA #TE 8
K812715 · Teca, Inc. · Oct 1981
CADWELL 7200
K800648 · Cadwell Laboratories, Inc. · Apr 1980
CADWELL 7000 ELECTROMYOGRAPH MACHINE
K791235 · Cadwell Laboratories, Inc. · Aug 1979
TECA MODEL B9 ELECTROMYOGRAPH
K781399 · Teca, Inc. · Sep 1978