FDA product code · Gastroenterology and urology

Implanted Tibial Electrical Urinary Continence Device

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

QXMClass II21 CFR 876.5305510(k) required4 decisions since 20230 recalls

4 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 126 days (half between 122 and 130). No recall names this code. The most-cited predicate is K240037, named by 2 later devices.

An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.

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 QXM 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 · QXM

1in 2025

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXM

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

Recalls per year · QXM

No recall names QXM since 2007.

Adverse event reports per year · QXM

17in 2025

2007high 17 (2025) · low 0 (2007)2025

MAUDE reports naming product code QXM, 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	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	1	—	4
2025	1	—	17
2026	1	—	—

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

Planning a device in QXM? 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

Implanted Tibial Electrical Urinary Continence Device

Which predicates do QXM devices cite most?

Which QXM devices have the deepest lineage?

What has FDA decided in QXM lately?