510(k) Report

FDA product code · General hospital

Respiratory Accessory Microbial Reduction Device.

QXQClass II21 CFR 880.6993510(k) required3 decisions since 20242 recalls

3 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 303 days (half between 303 and 303). 2 recalls name this code, 0 of them Class I. The most-cited predicate is DEN210037, named by 2 later devices.

A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions.

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 hospital panel

Twenty years of QXQ 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 · QXQ

1in 2025

2024: 12025: 12026 (partial year): 1
2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXQ

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

Recalls per year · QXQ

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QXQ

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code QXQ, 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
20210—00
20220—00
20230—20
20241—00
20251—01
20261—0—
FIG. 1 — QXQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QXQ? 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