FDA product code · General and plastic surgery

Skin Patch For Treatment Of Hyperhidrosis

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

QVXClass II21 CFR 878.4425510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. No recall names this code.

A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.

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, general and plastic surgery panel

Twenty years of QVX 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 · QVX

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QVX

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

Recalls per year · QVX

No recall names QVX since 2007.

Adverse event reports per year · QVX

No MAUDE report names QVX since 2007.

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	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in QVX? 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

Skin Patch For Treatment Of Hyperhidrosis

What has FDA decided in QVX lately?