510(k) · Cleared
ClearedVentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · NHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Cleared on Apr 8, 2016 as substantially equivalent to K011812 (Cook, Inc., 2001) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Apr 8, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- NHC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011812 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011812 Spectrum Ventricular CatheterCook, Inc. · 2001 · Recalled
- 1 generation backK071640 Ventriclear II, Spectrum Ventricular Drainage Catheter, Model…Cook, Inc. · 2007 · Recalled
- This deviceK160223 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum…Cook Incorporated · 2016
- Descendant · cites it directly · 4 of its ownK171880 IRRAflow CNS SystemIrras, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK192289 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK200807 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK222471 IRRAflow Active Fluid Exchange System (AFES)Irras USA · 2022
- Descendant · 4 generations on · 0 of its ownK231664 IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K171880IRRAflow CNS SystemIrras, Inc. · 2018 · cites it directly4descendants
- K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019 · 2 generations on3descendants
- K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020 · 2 generations on2descendants
- K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA · 2022 · 3 generations on1descendant
- K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011812 | Spectrum Ventricular Catheter | Cook, Inc. | 2001 | 1 |
| −1 | K071640 | Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm | Cook, Inc. | 2007 | 1 |
| 0 (this device) | K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic… | Cook Incorporated | 2016 | — |
| +1 | K171880 | IRRAflow CNS System | Irras, Inc. | 2018 | — |
| +2 | K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | 2019 | — |
| +2 | K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | 2020 | — |
| +3 | K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA | 2022 | — |
| +4 | K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K011812 | Spectrum Ventricular CatheterSummary page 4…Antimicrobial Agents) NHC (21 CFR §882.4100) Class: Class II Predicate Devices: K011812, Spectrum® Ventricular Catheter K071640, VentriClear® II Ventricular Drainage Catheter Set Device Description:… | 2001 |
| * | K071640 | Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-AbrmSummary page 4…NHC (21 CFR §882.4100) Class: Class II Predicate Devices: K011812, Spectrum® Ventricular Catheter K071640, VentriClear® II Ventricular Drainage Catheter Set Device Description: The VentriClear® Ventricular Drainage Catheter S… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171880 | IRRAflow CNS System | 2018 | 4 |
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 15 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K171880 (Irras, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K011812.
How does its category compare?
All NHC devicesNHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NHC
1in 2016
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHC
3in 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 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and the VentriClear II Ventricular Drainage Catheter have been designed 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/K160223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160223: VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160223
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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