510(k) · Cleared

Cleared

Alcyone MEMS Cannula (AMC) System

K150660510(k) TraditionalCleared Apr 16, 201534-day reviewClass I21 CFR 882.4060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alcyone Lifesciences, Inc. · HCD Cannula, Ventricular

Cleared on Apr 16, 2015 as substantially equivalent to K102101 (Surgivision, Inc., 2011) after a 34-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.

Decided: Apr 16, 2015
Review: 34 days
Class: Class I
Product code: HCD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K102101 (2011). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK102101 Surgivision MR Compatible Ventricular CannulaSurgivision, Inc. · 2011
This deviceK150660 Alcyone MEMS Cannula (AMC) SystemAlcyone Lifesciences, Inc. · 2015
Descendant · cites it directly · 0 of its ownK161731 Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017

Most influential descendants

Showing 1 of 1 · See all

K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K102101	Surgivision MR Compatible Ventricular Cannula	Surgivision, Inc.	2011	—
0 (this device)	K150660	Alcyone MEMS Cannula (AMC) System	Alcyone Lifesciences, Inc.	2015	—
+1	K161731	Cleveland Multiport Ventricular Catheter Set	Parker Hannifin Corp.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K150660, 2011–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HCD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K102101	Surgivision MR Compatible Ventricular Cannula Summary page 4 …: Class I Product Code and Regulation: HCD, 21 CFR 882.4060 Classification Panel: Neurology Predicate Device: K102101 SurgiVision, Inc. MR Compatible Ventricular Cannula (a.k.a., MRI Interventions Inc., SmartFlow Ven…	Surgivision, Inc.	2011	—

Also cleared against K102101: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161731	Cleveland Multiport Ventricular Catheter Set	Parker Hannifin Corp.	2017	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K161731 (Parker Hannifin Corp., 2017) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K102101.

How does its category compare?

All HCD devices

HCD Cannula, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · HCD

1in 2015

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCD

Too few HCD 510(k)s in any year since 2007 to give a median.

Recalls per year · HCD

No recall names HCD since 2007.

Adverse event reports per year · HCD

10in 2019

2007high 10 (2019) · low 0 (2007)2025

MAUDE reports naming product code HCD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	1
2017	0	—	0
2018	0	—	6
2019	0	—	10
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Alcyone MEMS Cannula (AMC) System consisting of the AMC and the AMC Extension Line Set, is intended for injection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150660: Alcyone MEMS Cannula (AMC) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150660

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026