Cleared Traditional

K920088 - CAMINO VENTRICULAR NEEDLE

K920088 is an FDA 510(k) clearance for CAMINO VENTRICULAR NEEDLE, manufactured by Camino Laboratories, Inc.. The device is a Class 1 Neurology device with product code HCD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

FDA 510(k) Submission Details - K920088

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

HCD Device Classification - Class 1, General Controls

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.