FDA applicant
Somnomed, Inc.
FDA records 12 decisions for Somnomed, Inc. (Frisco, TX) from 2005 to 2026: 12 510(k) clearances. Most are in product codes LRK (Device, Anti-Snoring) and PLC (Sleep Appliances With Patient Monitoring). Since 2016 its 510(k)s took a median of 46 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 16 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Somnomed, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Somnomed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Somnomed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Somnomed”
FDA records each applicant name separately; these may or may not be the same firm.