Cleared Traditional

K011429 - MODEL 100 ACTIVITY MONITOR

K011429 is an FDA 510(k) clearance for MODEL 100 ACTIVITY MONITOR, manufactured by Telecom Medical, Inc.. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K011429 · Telecom Medical, Inc. · Neurology device
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Jul 2001
Decision
65d
Days
Class 2
Risk

K011429 is an FDA 510(k) clearance for the MODEL 100 ACTIVITY MONITOR. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Telecom Medical, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 13, 2001 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1950 - 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.

FDA 510(k) Submission Details - K011429

510(k) Number K011429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2001
Decision Date July 13, 2001
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 149d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYD Device Classification - Class 2, Special Controls

Product Code GYD Transducer, Tremor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1950
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 - GYD Transducer, Tremor

All 14
Devices cleared under the same product code (GYD) and FDA review panel - the closest regulatory comparables to K011429.
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · Gkc Manufacturing Pty, Ltd. · Aug 2014
KINESIA
K063872 · Cleveland Medical Devices, Inc. · Apr 2007
TREMOROMETER
K010270 · Flexable Systems, Inc. · Jul 2001
MM-1 MOVEMENT MONITOR
K971318 · Axon Instruments, Inc. · Jul 1997
TREMOR MONITOR
K782036 · Columbus Instruments Intl. Corp. · Jan 1979
K011429 · MODEL 100 ACTIVITY MONITOR
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