Cleared Traditional

K150660 - Alcyone MEMS Cannula (AMC) System

K150660 is an FDA 510(k) clearance for Alcyone MEMS Cannula (AMC) System, manufactured by Alcyone Lifesciences, Inc.. The device is a Class 1 Neurology device with product code HCD cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K150660 · Alcyone Lifesciences, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K150660

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 149d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.