Cleared Traditional

K911529 - BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG

K911529 is an FDA 510(k) clearance for BUNNY ELECTRODE/STEALTH ELECTRODE PRE W..., manufactured by Lead-Lok, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 585-day FDA review.

K911529 · Lead-Lok, Inc. · Cardiovascular device
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Nov 1992
Decision
585d
Days
Class 2
Risk

K911529 is an FDA 510(k) clearance for the BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Lead-Lok, Inc. (Sandpoint, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 585 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Lead-Lok, Inc. devices

FDA 510(k) Submission Details - K911529

510(k) Number K911529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date November 09, 1992
Days to Decision 585 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
460d slower than avg
Panel avg: 125d · This submission: 585d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 176
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K911529.
TRACET T-6000
K930258 · Lectec Corp. · Apr 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
ECG ELECTRODE
K923558 · Lectec Corp. · Feb 1993
DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION
K921207 · Physiometrix, Inc. · Oct 1992
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · Cardiotronics, Inc. · Sep 1991
TRACETS SME 5000
K912450 · Lectec Corp. · Aug 1991