Cleared Traditional

K800648 - CADWELL 7200

K800648 is an FDA 510(k) clearance for CADWELL 7200, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K800648 · Cadwell Laboratories, Inc. · Neurology device
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Apr 1980
Decision
28d
Days
Class 2
Risk

K800648 is an FDA 510(k) clearance for the CADWELL 7200. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980 after a review of 28 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K800648

510(k) Number K800648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1980
Decision Date April 21, 1980
Days to Decision 28 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
120d faster than avg
Panel avg: 148d · This submission: 28d
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 22
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K800648.
ANESTHESIA & BRAIN MONITOR
K821910 · Datex Division Instrumentarium Corp. · Sep 1982
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K812715 · Teca, Inc. · Oct 1981
TECA MODEL-10 ELECTROMYOGRAPH
K802637 · Teca, Inc. · Nov 1980
CADWELL 7000 ELECTROMYOGRAPH MACHINE
K791235 · Cadwell Laboratories, Inc. · Aug 1979
TECA MODEL B9 ELECTROMYOGRAPH
K781399 · Teca, Inc. · Sep 1978