FDA product code · Neurology

Lumbar Drainage Catheter Kit

Name: FDA decisions, review times, recalls and adverse event reports for product code PVO
Creator: 510(k) Report

PVOClass II21 CFR 882.55500 decisions0 recalls

0 FDA decisions. No recall names this code.

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if…

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 PVO 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 · PVO

FDA has decided no PVO device since 2007.

Median 510(k) review, days · PVO

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

Recalls per year · PVO

No recall names PVO since 2007.

Adverse event reports per year · PVO

1in 2024

2007high 1 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	1
2025	—	0
2026	—	—

FIG. 1 — PVO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PVO? 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 882.5550.

LKG Port & Catheter, Implanted, Subcutaneous…JXG Shunt, Central Nervous System And Components PVL Endoscopic Shunt Placement Kit