Cleared Traditional

K934368 - NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (FDA 510(k) Clearance)

Class I Neurology device.

K934368 · Nk Biotechnical Engineering Co. · Neurology device
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Aug 1994
Decision
338d
Days
Class 1
Risk

K934368 is an FDA 510(k) clearance for the NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on August 11, 1994 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nk Biotechnical Engineering Co. devices

Submission Details

510(k) Number K934368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date August 11, 1994
Days to Decision 338 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 148d · This submission: 338d
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.