Chrysalis Intelligence · Product Codes · DRT

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

Cardiovascular · 12 clearances · 8 unique sponsors

Device class
Class II
Regulation 870.2300
Total clearances
12
2021-04-26 → 2026-09-25
Last 12 months
4
Unique sponsors
8
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
Xandar Kardian, Inc. 1 0 2021-04-26
Ivy Biomedical Systems, Inc. 1 0 2021-05-14
Circadia Technologies, Ltd. 1 0 2024-05-30
Life Detection Technologies 1 1 2026-09-25
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
2026-09-25 K254058 Life Detection Technologies DistaSense(TM) (v1)
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)