Vital Sign Monitoring Sensor (Model :XK300)— 510(k) K202464

Name: FDA 510(k) clearance K202464
Creator: U.S. Food and Drug Administration
Published: 2021-04-26

Substantially Equivalent

Xandar Kardian, Inc.

FDA 510(k) clearance K202464 for Vital Sign Monitoring Sensor (Model :XK300), Substantially Equivalent on 2021-04-26. Applicant: Xandar Kardian, Inc.. Device class: 2.

Clearance details

Applicant: Xandar Kardian, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2020-08-27
Decision date: 2021-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRT

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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
K234003 — The Circadia C200 System2024-05-30

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.