Cleared Traditional

K012850 - RECORDING AND STIMULATING ELECTRODE

K012850 is an FDA 510(k) clearance for RECORDING AND STIMULATING ELECTRODE, manufactured by Radionics, A Division of Tyco Healthcare Group LP. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K012850 · Radionics, A Division of Tyco Healthcare Group LP · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
87d
Days
Class 2
Risk

K012850 is an FDA 510(k) clearance for the RECORDING AND STIMULATING ELECTRODE. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Radionics, A Division of Tyco Healthcare Group LP (Burlington, US). The FDA issued a Cleared decision on November 19, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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 Radionics, A Division of Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K012850

510(k) Number K012850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2001
Decision Date November 19, 2001
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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.