Onera B.V.

FDA Regulatory Profile

Onera B.V. appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 8, 2026.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253668Onera SleepMap (SLEEPMAP)March 8, 2026
K243220Onera STS 2 (ONERA STS 2)July 3, 2025
K223573Onera Sleep Test System (Onera STS)August 18, 2023
K210593Onera Sleep Test System (Onera STS)April 6, 2022