The Circadia C200 System— 510(k) K234003

Name: FDA 510(k) clearance K234003
Creator: U.S. Food and Drug Administration
Published: 2024-05-30

Substantially Equivalent

Circadia Technologies, Ltd.

FDA 510(k) clearance K234003 for The Circadia C200 System, Substantially Equivalent on 2024-05-30. Applicant: Circadia Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Circadia Technologies, Ltd.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2023-12-19
Decision date: 2024-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRT

view all

K261286 — The Circadia C300 System (C300)2026-05-20
K252676 — The Circadia C300 System (C300)2026-02-03
K253388 — Sleepiz One+ (Model 2.5)2026-01-28
K251364 — Sleepiz One+ (2.5)2025-07-29
K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software2024-03-22

More clearances from Circadia Technologies, Ltd.

view all

K200445 — The C100 Contactless Breathing Monitor2020-06-24

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.