FDA product code · Ear, nose and throat

Balloon, Nasal Airway

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

QGKClass I21 CFR 874.4420510(k) exempt1 decision since 20190 recalls

FDA lists QGK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2019. No recall names this code. The most-cited predicate is K183090, named by 1 later device.

The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.

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 QGK 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 · QGK

1in 2019

2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QGK

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

Recalls per year · QGK

No recall names QGK since 2007.

Adverse event reports per year · QGK

5in 2024

2007high 5 (2024) · low 0 (2007)2025

MAUDE reports naming product code QGK, 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	0	—	2
2021	0	—	1
2022	0	—	1
2023	0	—	0
2024	0	—	5
2025	0	—	0
2026	0	—	—

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

Planning a device in QGK? 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

Related product codes

Other codes under 21 CFR 874.4420.

KBG Trocar, Sinus KBL Depressor, Metal Tongue, Surgical KAS Knife, Nasal KBB Rongeur, Nasal KCH Hook, Tracheal KBQ Knife, Tonsil JZF Tube, Ear Suction KAQ Gouge, Nasal, Ent KAP Curette, Nasal KAB Trocar, Laryngeal KBH Adenotome KAW Punch, Antrum

Balloon, Nasal Airway

Which predicates do QGK devices cite most?

What has FDA decided in QGK lately?

Related product codes