510(k) Report

FDA applicant

Inspire Medical Systems

Maple Grove1 decision2014–20143 recalls

FDA records 1 decision for Inspire Medical Systems (Maple Grove) in 2014: 1 original PMA approval. All are in product code MNQ (Stimulator, Hypoglossal Nerve, Implanted, Apnea). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Inspire Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2026

2018: 12026 (partial year): 2
2014high 2 (2026) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Inspire Medical Systems by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNQStimulator, Hypoglossal Nerve, Implanted, Apnea1decision

What has FDA decided for it lately?

  • P130008Inspire II Upper Airway StimulatorInspire Medical Systems · 20143 recalls

The one decision as Inspire Medical Systems →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P130008Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead…May 11, 2026Class II
  • P130008Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead…May 11, 2026Class II
  • P130008Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea…Jun 12, 2018Class II