Cleared Special

K261286 - The Circadia C300 System (C300)

K261286 is an FDA 510(k) clearance for The Circadia C300 System (C300), manufactured by Circadia Health, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Special 510(k) pathway after a 30-day FDA review.

K261286 · Circadia Health, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
30d
Days
Class 2
Risk

K261286 is an FDA 510(k) clearance for the The Circadia C300 System (C300). Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Circadia Health, Inc. (El Segundo, US). The FDA issued a Cleared decision on May 20, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K261286

510(k) Number K261286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2026
Decision Date May 20, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 340
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K261286.
The Circadia CX00 System (CX00)
K262447 · Circadia Health, Inc. · Oct 2026
DistaSense(TM) (v1)
K254058 · Life Detection Technologies · Sep 2026
The Circadia C300 System (C300)
K252676 · Circadia Health, Inc. · Feb 2026
Sleepiz One+ (Model 2.5)
K253388 · Sleepiz AG · Jan 2026
Sleepiz One+ (2.5)
K251364 · Sleepiz AG · Jul 2025
The Circadia C200 System
K234003 · Circadia Technologies, Ltd. · May 2024
K261286 · The Circadia C300 System (C300)
Download PDF FDA Summary Circadia Health, Inc.