Cleared Traditional

TIGER PULSE (K830325) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830325 · Bertone & Assoc. · Neurology device
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Mar 1983
Decision
28d
Days
Class 2
Risk

K830325 is an FDA 510(k) clearance for the TIGER PULSE. Classified as Electrode, Nasopharyngeal (product code GZK), Class II - Special Controls.

Submitted by Bertone & Assoc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1340 - 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 Bertone & Assoc. devices

Submission Details

510(k) Number K830325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1983
Decision Date March 01, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code GZK Electrode, Nasopharyngeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1340
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.