510(k) Report

FDA product code · Neurology

Catheter, Percutaneous, Neurovasculature

QJPClass II21 CFR 870.1250510(k) required103 decisions since 20201 recall

103 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 165 days (half between 87 and 247). 1 recall names this code; it is not Class I. The most-cited predicate is K212838, named by 4 later devices.

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

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 QJP 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 · QJP

22so far in 2026, the most since 2007

2020: 92021: 122022: 142023: 142024: 182025: 142026 (partial year): 22
2007high 22 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJP

116in 2025

2020: 72 days median2021: 139 days median2022: 206 days median2023: 184 days median2024: 188 days median2025: 116 days median2026 (partial year): 141 days median
2007high 206 (2022) · low 72 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QJP

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QJP

688in 2025

2020: 162021: 292022: 302023: 752024: 1302025: 688
2007high 688 (2025) · low 0 (2007)2025

MAUDE reports naming product code QJP, 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
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
2020972016
202112139029
202214206030
202314184075
2024181881130
2025141160688
2026221410—
FIG. 1 — QJP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QJP? 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 870.1250.