510(k) Report

FDA product code · Neurology

Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

NHCClass II21 CFR 882.4100510(k) required3 decisions since 20011 recall

3 FDA decisions since 2001. 1 recall names this code; it is not Class I. The most-cited predicate is K011812, named by 3 later devices.

Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.

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

FIG. A — Illustration, neurology panel

Twenty years of NHC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NHC

1in 2016

2007: 12016: 1
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

2015: 1
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

2007: 12010: 12012: 12013: 12015: 32016: 52017: 72018: 52019: 22020: 92022: 12024: 42025: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—00
20090—00
20100—01
20110—00
20120—01
20130—01
20140—00
20150—13
20161—05
20170—07
20180—05
20190—02
20200—09
20210—00
20220—01
20230—00
20240—04
20250—03
20260—0—
FIG. 1 — NHC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NHC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 882.4100.