510(k) · Cleared

Recalled · Class II · 2015

Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm

K071640510(k) SpecialCleared Jul 12, 200727-day reviewClass II21 CFR 882.4100Recalls 1

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

Cook, Inc. · NHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

Cleared on Jul 12, 2007 as substantially equivalent to K011812 (Cook, Inc., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it. It has been recalled once.

Decided: Jul 12, 2007
Review: 27 days
Class: Class II
Product code: NHC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K011812 (2001). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011812 Spectrum Ventricular CatheterCook, Inc. · 2001 · Recalled
This deviceK071640 Ventriclear II, Spectrum Ventricular Drainage Catheter, Model…Cook, Inc. · 2007
Descendant · cites it directly · 5 of its ownK160223 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum…Cook Incorporated · 2016
Descendant · 2 generations on · 4 of its ownK171880 IRRAflow CNS SystemIrras, Inc. · 2018
Descendant · 3 generations on · 3 of its ownK192289 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019
Descendant · 3 generations on · 2 of its ownK200807 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020
Descendant · 4 generations on · 1 of its ownK222471 IRRAflow Active Fluid Exchange System (AFES)Irras USA · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2016high 1 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 6 · See all

K160223VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…Cook Incorporated · 2016 · cites it directly5descendants
K171880IRRAflow CNS SystemIrras, Inc. · 2018 · 2 generations on4descendants
K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019 · 3 generations on3descendants
K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020 · 3 generations on2descendants
K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA · 2022 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011812	Spectrum Ventricular Catheter	Cook, Inc.	2001	1
0 (this device)	K071640	Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm	Cook, Inc.	2007	—
+1	K160223	VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…	Cook Incorporated	2016	—
+2	K171880	IRRAflow CNS System	Irras, Inc.	2018	—
+3	K192289	IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit	Irras USA, Ltd.	2019	—
+3	K200807	IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit	Irras USA, Inc.	2020	—
+4	K222471	IRRAflow Active Fluid Exchange System (AFES)	Irras USA	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K071640, 2001–2023Source: 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 NHC? 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

Get a 510(k) Report

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
*	K011812	Spectrum Ventricular Catheter	Cook, Inc.	2001	1

Also cleared against K011812: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K160223	VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…	Cook Incorporated	2016	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 19, 2015	Class II	Z-0416-2016	Process control	Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K160223 (Cook Incorporated, 2016) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K011812.

How does its category compare?

All NHC devices

NHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NHC

1in 2016

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHC

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

Recalls per year · NHC

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHC

3in 2025

2007high 9 (2020) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	1
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	1
2011	0	—	0	0
2012	0	—	0	1
2013	0	—	0	1
2014	0	—	0	0
2015	0	—	1	3
2016	1	—	0	5
2017	0	—	0	7
2018	0	—	0	5
2019	0	—	0	2
2020	0	—	0	9
2021	0	—	0	0
2022	0	—	0	1
2023	0	—	0	0
2024	0	—	0	4
2025	0	—	0	3
2026	0	—	0	—

What is it indicated for?

Intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071640 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071640: Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071640

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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