510(k) Report

510(k) · Cleared

Cleared

Cleveland Multiport Ventricular Catheter Set

K161731510(k) TraditionalCleared Mar 27, 2017277-day reviewClass II21 CFR 882.4100

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

Parker Hannifin Corp. · HCA Catheter, Ventricular

Cleared on Mar 27, 2017 as substantially equivalent to K123605 (Mri Interventions, Inc., 2013) and 2 other predicates after a 277-day review. Its family tree reaches back 2 generations to 2011.

Decided
Mar 27, 2017
Review
277 days
Class
Class II
Product code
HCA
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K102101 (2011). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestorK102101 · Surgivision MR Compatible Ventricular Cannula · Surgivision, Inc. · 2011K123605 · Smartflow Catheter · Mri Interventions, Inc. · 201320102012201420162018
Other ancestors, by generation 1 generation back: 1 other ancestor K123605 · Smartflow Catheter · Mri Interventions, Inc. · 2013K102101 · Surgivision MR Compatible Ventricular Cannula · Surgivision, Inc. · 20110
  1. Root · 2 generations backK102101 Surgivision MR Compatible Ventricular CannulaSurgivision, Inc. · 2011
  2. 1 generation backK123605 Smartflow CatheterMri Interventions, Inc. · 2013
  3. This deviceK161731 Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K102101Surgivision MR Compatible Ventricular CannulaSurgivision, Inc.2011—
−1K123605Smartflow CatheterMri Interventions, Inc.2013—
0 (this device)K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K161731, 2011–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HCA? 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K123605Smartflow Catheter
Summary page 4
…ode: HCA Device Classification: 21 CFR 882.4100 Regulatory Class: Class II Predicate Device: MRI SmartFlow Flex Ventricular Catheter #K123605. Intended Use / Indications for Use The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the vent…
Mri Interventions, Inc.2013—
*K150660Alcyone MEMS Cannula (AMC) System
Summary page 6
…tricular Ventricular Catheter, Cannula System, Ventricular Cannula, Catheter Set K123605 K150660 K102101 Classification 21 CFR 882.4100 21 CFR 882.4100 21 CFR 882.4060…
Alcyone Lifesciences, Inc.2015—
*K102101Surgivision MR Compatible Ventricular Cannula
Summary page 6
…atheter, Cannula System, Ventricular Cannula, Catheter Set K123605 K150660 K102101 Classification 21 CFR 882.4100 21 CFR 882.4100 21 CFR 882.4060 21 CFR 882.4060…
Surgivision, Inc.2011—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
  • None of the 3 ancestors has a recall.

How does its category compare?

All HCA devices

HCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HCA

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCA

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

Recalls per year · HCA

No recall names HCA since 2007.

Adverse event reports per year · HCA

1in 2021

2007: 82008: 32009: 12010: 42011: 192012: 12015: 22016: 12017: 32019: 22020: 12021: 1
2007high 19 (2011) · low 0 (2013)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—08
20080—03
20090—01
20100—04
20110—019
20120—01
20131—00
20140—00
20150—02
20160—01
20171—03
20180—00
20190—02
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the

removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.

Indications for use as stated in the FDA summary.

More from Parker Hannifin Corp.

8 FDA decisions under this applicant name. See the company

  • K897086Parker Ambulatory Medication Infusion Pump 2004Parker Hannifin Corp. · 1990
  • K863532Modified Labeling to Model 2000 Ambulatory InfuserParker Hannifin Corp. · 1987
  • K833723Model 2000 Ambulatory Med. InfuserParker Hannifin Corp. · 1984
  • K834461Infusion Pump PrimerParker Hannifin Corp. · 1984
  • K831402Pressure Monitor & Control Unit Apc-02AParker Hannifin Corp. · 1983

Recent decisions in HCA

The HCA category page

  • K123605Smartflow CatheterMri Interventions, Inc. · 2013
  • K031123Codman Bactiseal Barium Striped CathetersCodman & Shurtleff, Inc. · 20031 recall
  • K021481Bresagen Catheter, Model CS-3000Bresagen, Inc. · 2002
  • K020728Miethke Shunt SystemAesculap, Inc. · 20021 recall
  • K013005Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002

https://510kreport.com/device/K161731 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161731: Cleveland Multiport Ventricular Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161731

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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