510(k) · Cleared

Recalled · Class II · 2018

Spectrum Ventricular Catheter

K011812510(k) TraditionalCleared Nov 8, 2001150-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 Nov 8, 2001 after a 150-day review. The FDA summary names its predicate without a number. 15 of the 135 devices in its family, counting itself, have a Class I recall. 134 later devices descend from it. It has been recalled once.

Decided: Nov 8, 2001
Review: 150 days
Class: Class II
Product code: NHC
Recalls: 1
Predicates: 0

134 later devices descend from it, 3 citing it directly. 15 of the 135 devices in this family, counting this one, have a Class I recall.

This deviceK011812 Spectrum Ventricular CatheterCook, Inc. · 2001
Descendant · cites it directly · 126 of its ownK021557 Spectrum Silicone CatheterCook, Inc. · 2003
Descendant · 2 generations on · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
Descendant · 3 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
Descendant · 3 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
Descendant · 4 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

2003high 16 (2012) · low 0 (2004)2026

Class I recalls in this family

K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…4 generations on · 2007
K210264 BD PowerPiCC Catheter4 generations on · 2021
K113277 Arrowadvantages Pressure Injectable Peripherally…4 generations on · 2012
K143102 Multi-Lumen Acute Hemodialysis Catheter for High…4 generations on · 2015

Most influential descendants

Showing 5 of 134 · See all

K021557Spectrum Silicone CatheterCook, Inc. · 2003 · cites it directly126descendants
K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · 2 generations on119descendants
K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 3 generations on66descendants
K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 3 generations on47descendants
K091953Pro-PiccMedcomp · 2009 · 4 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011812	Spectrum Ventricular Catheter	Cook, Inc.	2001	—
+1	K021557	Spectrum Silicone Catheter	Cook, Inc.	2003	—
+2	K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	—
+3	K070996	4 FR Single Lumen (SL) Powerpicc Catheter	C.R. Bard, Inc.	2007	—
+3	K061179	Powerhickman Long-Term Intravascular Catheter	C.R. Bard, Inc.	2006	—
+4	K091953	Pro-Picc	Medcomp	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	2	0
2007	5	1
2008	2	0
2009	6	0
2010	7	1
2011	5	0
2012	16	3
2013	14	2
2014	13	2
2015	7	2
2016	14	2
2017	4	0
2018	10	0
2019	5	0
2020	7	0
2021	1	1
2022	4	1
2023	4	0
2025	6	0

FIG. 1 — Lineage of K011812, 2001–2025Source: 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.

15 devices in this family have a Class I recall. 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
*	—	Cook Incorporated’s Ventricular Catheter Named without a submission number			—

What descends from it? (134)

See all 134

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021557	Spectrum Silicone Catheter	Cook, Inc.	2003	126
K071640	Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm	Cook, Inc.	2007	6
K160223	VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…	Cook Incorporated	2016	5

Has anything in its family been recalled? (15 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 31, 2018	Class II	Z-2791-2018	Release of Material/Component prior to receiving test results	This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

Nearest 12 of 15 shown.

Nearest 5 of 15; all are on the web page.

What does this lineage say?

Of its descendants, K021557 (Cook, Inc., 2003) has gone furthest, with 126 descendants of its own.

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.

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?

The SPECTRUM® Ventricular Catheter is 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 of fluid volume. The device will be supplied sterile and is intended for one-time use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011812 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011812: Spectrum Ventricular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011812

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026