510(k) Report

FDA product code · Ear, nose and throat

Suction Anti-Choking Device As A Second-Line Treatment

QXNClass II21 CFR 874.5400510(k) required1 decision since 20260 recalls

1 FDA decision since 2026. No recall names this code.

A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.

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, ear, nose and throat panel

Twenty years of QXN 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 · QXN

1so far in 2026, the most since 2007

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

2026 to Oct 25, outlined.

Median 510(k) review, days · QXN

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

Recalls per year · QXN

No recall names QXN since 2007.

Adverse event reports per year · QXN

No MAUDE report names QXN since 2007.

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—00
20240—00
20250—00
20261—0—
FIG. 1 — QXN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QXN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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