510(k) Report

FDA product code · Cardiovascular

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

QRJClass II21 CFR 870.5125510(k) required1 decision since 20210 recalls

1 FDA decision since 2021. No recall names this code.

A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.

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 QRJ 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 · QRJ

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRJ

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

Recalls per year · QRJ

No recall names QRJ since 2007.

Adverse event reports per year · QRJ

7in 2025

2022: 32023: 12024: 42025: 7
2007high 7 (2025) · low 0 (2007)2025

MAUDE reports naming product code QRJ, 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
20200—00
20211—00
20220—03
20230—01
20240—04
20250—07
20260—0—
FIG. 1 — QRJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QRJ? 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