Chrysalis Intelligence · Product Codes · DRT

DRT · Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cardiovascular · 11 clearances · 7 unique sponsors

Device class
Class II
Regulation 870.2300
Total clearances
11
2021-04-26 → 2026-05-20
Last 12 months
3
Unique sponsors
7
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.2300
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Sleepiz AG 3 1 2026-01-28
Circadia Health, Inc. 2 2 2026-05-20
Neteera Technologies , Ltd. 2 0 2024-02-09
Ivy Biomedical Systems, Inc. 1 0 2021-05-14
Xandar Kardian, Inc. 1 0 2021-04-26
Circadia Technologies, Ltd. 1 0 2024-05-30
Murata Vios, Inc. 1 0 2024-03-22
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
93000 CPT High Standard CPT for cardiac monitoring and cardiotachometer services
93005 CPT Medium ECG tracing with interpretation, cardiac monitoring context
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-20 K261286 Circadia Health, Inc. The Circadia C300 System (C300)
2026-02-03 K252676 Circadia Health, Inc. The Circadia C300 System (C300)
2026-01-28 K253388 Sleepiz AG Sleepiz One+ (Model 2.5)
2025-07-29 K251364 Sleepiz AG Sleepiz One+ (2.5)
2024-05-30 K234003 Circadia Technologies, Ltd. The Circadia C200 System
2024-03-22 K232354 Murata Vios, Inc. Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
2024-02-09 K231733 Neteera Technologies , Ltd. Neteera 130H-Plus Vital Sign Monitoring Sensor
2023-08-18 K223163 Sleepiz AG Sleepiz One+
2022-09-28 K212143 Neteera Technologies , Ltd. Neteera 130H/131H Vital Sign Monitoring Sensor
2021-05-14 K202138 Ivy Biomedical Systems, Inc. Cardiac Trigger Monitor
2021-04-26 K202464 Xandar Kardian, Inc. Vital Sign Monitoring Sensor (Model :XK300)