510(k) Report

FDA product code · Cardiovascular

Catheter, Infusion, Syringe

NPGClass II21 CFR 870.1210510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. 510(k) reviews decided 2021–2025 took a median of 265 days (half between 265 and 265). No recall names this code.

To provide physician specified fluids both perivascular or intraluminal to the perivascular space.

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, cardiovascular panel

Twenty years of NPG 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 · NPG

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPG

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

Recalls per year · NPG

No recall names NPG since 2007.

Adverse event reports per year · NPG

No MAUDE report names NPG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — NPG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Related product codes

Other codes under 21 CFR 870.1210.