Cleared Traditional

K150660 - Alcyone MEMS Cannula (AMC) System (FDA 510(k) Clearance)

Class I Neurology device.

K150660 · Alcyone Lifesciences, Inc. · Neurology device
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Apr 2015
Decision
34d
Days
Class 1
Risk

K150660 is an FDA 510(k) clearance for the Alcyone MEMS Cannula (AMC) System. Classified as Cannula, Ventricular (product code HCD), Class I - General Controls.

Submitted by Alcyone Lifesciences, Inc. (Lowell, US). The FDA issued a Cleared decision on April 16, 2015 after a review of 34 days - a notably fast clearance cycle.

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: 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 Alcyone Lifesciences, Inc. devices

Submission Details

510(k) Number K150660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2015
Decision Date April 16, 2015
Days to Decision 34 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 148d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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.