FDA product code · Gastroenterology and urology

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

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

QHHClass II21 CFR 876.5340510(k) required6 decisions since 20190 recalls

6 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 131 days (half between 103 and 165). No recall names this code. The most-cited predicate is DEN180057, named by 3 later devices.

A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.

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 QHH 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 · QHH

2in 2025

2007high 2 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QHH

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

Recalls per year · QHH

No recall names QHH since 2007.

Adverse event reports per year · QHH

2in 2023

2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code QHH, 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	1	—	0
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	2
2024	1	—	0
2025	2	—	0
2026	0	—	—

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

Planning a device in QHH? 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

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Which predicates do QHH devices cite most?

Which QHH devices have the deepest lineage?

What has FDA decided in QHH lately?