510(k) Report

FDA product code · Anesthesiology

Stimulator, Hypoglossal Nerve, Implanted, Apnea

MNQClass IIIPMA required3 decisions since 20144 recalls

3 FDA decisions since 2014. 4 recalls name this code, 0 of them Class I.

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, anesthesiology panel

Twenty years of MNQ 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 · MNQ

18so far in 2026, the most since 2007

2014: 42015: 52016: 92017: 112018: 62019: 92020: 162021: 122022: 132023: 132024: 122025: 172026 (partial year): 18
2007high 18 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNQ

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

Recalls per year · MNQ

2in 2024

2024: 22026 (partial year): 2
2007high 2 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MNQ

950in 2025

2014: 12015: 32016: 112017: 222018: 552019: 922020: 792021: 2182022: 2832023: 4602024: 6972025: 950
2007high 950 (2025) · low 0 (2007)2025

MAUDE reports naming product code MNQ, 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
20144—01
20155—03
20169—011
201711—022
20186—055
20199—092
202016—079
202112—0218
202213—0283
202313—0460
202412—2697
202517—0950
202618—2—
FIG. 1 — MNQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MNQ? 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