Inspire Medical Systems: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Inspire Medical Systems”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | 1 | 0 |
Review panels
- Anesthesiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130008 | PMA | INSPIRE II UPPER AIRWAY STIMULATOR | 2014-04-30 |
Recalls
6 product recalls in 4 recall events; 5 initiated in the last five years. Most recent: 2026-05-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Inspire Medical Systems is the lead sponsor of 8 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT07113288: Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study (Recruiting, started 2025-07-31)
- NCT06971796: EURO-STIM Registry (Recruiting, started 2025-05-26)
- NCT06851338: Pediatric Down Syndrome Post-Approval Study (Recruiting, started 2025-02)
- NCT06540716: Inspire Singapore Study (Recruiting, started 2024-08)
- NCT04457154: Pediatric Post-Approval Registry (Recruiting, started 2021-11-30)
SEC filings
Inspire Medical Systems, Inc. (INSP): EDGAR filings, CIK 1609550. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Inspire Medical Systems?
FDA lists 0 510(k) clearances under the applicant name “Inspire Medical Systems”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Inspire Medical Systems?
The most frequent FDA product codes under this applicant name are MNQ (Stimulator, Hypoglossal Nerve, Implanted, Apnea, 1).
Next steps
- See all 0 Inspire Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code MNQ, Inspire Medical Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.