Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Onera Health with 4 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Mar 8, 2026: Onera SleepMap (SLEEPMAP).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 8, 2026 | Onera SleepMap (SLEEPMAP)K253668 · OLZ | 510(k) clearances |
| Mar 8, 2026 | Onera SleepMap (SLEEPMAP)K253668 · Neurology | AI-enabled devices |
| Jul 3, 2025 | Onera STS 2 (ONERA STS 2)K243220 · MNR | 510(k) clearances |
| Aug 18, 2023 | Onera Sleep Test System (Onera STS)K223573 · MNR | 510(k) clearances |
| Apr 6, 2022 | Onera Sleep Test System (Onera STS)K210593 · MNR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
