FDA product code · Gastroenterology and urology

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

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

NQJClass II21 CFR 876.5540510(k) required4 decisions since 20030 recalls

4 FDA decisions since 2003. 510(k) reviews decided 2021–2025 took a median of 42 days (half between 35 and 48). No recall names this code. The most-cited predicate is K031689, named by 2 later devices.

Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

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, gastroenterology and urology panel

Twenty years of NQJ 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 · NQJ

1in 2025

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQJ

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

Recalls per year · NQJ

No recall names NQJ since 2007.

Adverse event reports per year · NQJ

2in 2022

2007high 4 (2014) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	0	—	4
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	2
2023	1	—	0
2024	0	—	0
2025	1	—	0
2026	0	—	—

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

Planning a device in NQJ? 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 876.5540.

NFK Kit, Repair, Catheter, Hemodialysis FJO Plier, Tube NNE Needle, Fistula, Reprocessed MSD Catheter, Hemodialysis, Implanted LFJ Catheter, Subclavian FJY Plier, Crimp FKA Dilator, Vessel NOO Clamp, Dialysis Arm NYU Catheter, Hemodialysis, Implanted, Coated KNR Adapter, A-V Shunt Or Fistula MPB Catheter, Hemodialysis, Non-Implanted PFH Venous Window Needle Guide

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Which predicates do NQJ devices cite most?

Which NQJ devices have the deepest lineage?

What has FDA decided in NQJ lately?

Related product codes