Cleared Traditional

K964815 - AP-4000, AIR PULSE SENSORY STIMULATOR (FDA 510(k) Clearance)

Class I Neurology device.

K964815 · Pentax Precision Instrument Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
279d
Days
Class 1
Risk

K964815 is an FDA 510(k) clearance for the AP-4000, AIR PULSE SENSORY STIMULATOR. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on September 4, 1997 after a review of 279 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K964815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date September 04, 1997
Days to Decision 279 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
131d slower than avg
Panel avg: 148d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLN Device, Vibration Threshold Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.