510(k) Report

FDA product code · Cardiovascular

Agent, Occluding, Vascular, Permanent

PJQClass IIIPMA required1 decision since 20150 recalls

1 FDA decision since 2015. No recall names this code.

The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.

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 PJQ 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 · PJQ

3in 2025

2015: 22016: 42017: 22018: 72019: 32020: 32021: 72022: 62023: 52024: 32025: 32026 (partial year): 3
2007high 7 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PJQ

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

Recalls per year · PJQ

No recall names PJQ since 2007.

Adverse event reports per year · PJQ

100in 2025

2015: 62016: 412017: 692018: 1102019: 1622020: 1522021: 1612022: 1802023: 1542024: 1122025: 100
2007high 180 (2022) · low 0 (2007)2025

MAUDE reports naming product code PJQ, 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
20152—06
20164—041
20172—069
20187—0110
20193—0162
20203—0152
20217—0161
20226—0180
20235—0154
20243—0112
20253—0100
20263—0—
FIG. 1 — PJQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PJQ? 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