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510(k) K261286

The Circadia C300 System (C300) by Circadia Health, Inc. — Product Code DRT

K261286 is an FDA 510(k) premarket notification submitted by Circadia Health, Inc. for the device "The Circadia C300 System (C300)". The FDA issued a decision of Substantially Equivalent on May 20, 2026. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Circadia Health, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2026
Date Received
April 20, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Circadia Health, Inc.

  • K252676 — The Circadia C300 System (C300) (February 3, 2026)

Other clearances for product code DRT

  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)

FDA data resources