Cleared Traditional

CAMINO VENTRICULAR NEEDLE (K920088) - FDA 510(k) Clearance

Class I Neurology device.

K920088 · Camino Laboratories, Inc. · Neurology device
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May 1992
Decision
114d
Days
Class 1
Risk

K920088 is an FDA 510(k) clearance for the CAMINO VENTRICULAR NEEDLE. Classified as Cannula, Ventricular (product code HCD), Class I - General Controls.

Submitted by Camino Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 1, 1992 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4060 - 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 Camino Laboratories, Inc. devices

Submission Details

510(k) Number K920088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date May 01, 1992
Days to Decision 114 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
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HCD Cannula, Ventricular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4060
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.