Cleared Traditional

K010270 - TREMOROMETER

K010270 is an FDA 510(k) clearance for TREMOROMETER, manufactured by Flexable Systems, Inc.. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K010270 · Flexable Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
177d
Days
Class 2
Risk

K010270 is an FDA 510(k) clearance for the TREMOROMETER. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Flexable Systems, Inc. (Fountain Hills, US). The FDA issued a Cleared decision on July 25, 2001 after a review of 177 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Flexable Systems, Inc. devices

FDA 510(k) Submission Details - K010270

510(k) Number K010270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2001
Decision Date July 25, 2001
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
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 11
Devices cleared under the same product code (GYD) and FDA review panel - the closest regulatory comparables to K010270.
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