DPS · Electrocardiograph · Chrysalis Intelligence

Device class

Class II

Regulation 870.2340

Total clearances

2020-01-10 → 2026-09-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.2340

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Edan Instruments, Inc.	4	1	2026-07-02
Ge Medical Systems Information Technologies, Inc.	3	1	2026-01-26
Bionet Co., Ltd.	3	0	2023-12-15
Masimo Corporation	3	0	2025-04-03
Cardiacsense	2	0	2024-05-02
Accurkardia, Inc.	2	1	2025-12-22
Philips Medical Systems	2	0	2021-06-30
Withings	2	1	2025-11-10
Ekgenius, LLC	1	0	2023-11-17
Wellysis Corp.	1	1	2026-09-25
Cardiologs Technologies	1	0	2021-11-18
B-Secur , Ltd.	1	0	2020-12-07
Coala Life AB	1	0	2022-04-14
Caf Medical Solutions, Inc.	1	0	2022-03-25
Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.	1	0	2023-07-28
Shenzhen LE Medical Technology Co., Ltd.	1	0	2024-06-07
Amcg Co., Ltd.	1	0	2024-04-05
Philips France Commercial	1	0	2025-08-06
Trismed Co., Ltd.	1	0	2023-11-21
Schiller AG	1	0	2020-03-02
Physiq, Inc.	1	0	2020-06-11
Mediblu Medical, LLC	1	0	2024-06-12
Imedrix Inc. (Formerly Piitech Inc.)	1	0	2020-01-10
Withings SA	1	0	2021-10-05
Medizin Systeme Boblingen GmbH	1	0	2022-12-02

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.

Code	Type	Description	Confidence	Rationale
93000	CPT	—	High	CPT 93000 is standard for electrocardiogram interpretation and report
93005	CPT	—	Medium	CPT 93005 for ECG tracing only without interpretation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-25	K254255	Wellysis Corp.	S-Patch CardioAI
2026-07-02	K252463	Edan Instruments, Inc.	SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
2026-01-26	K251670	Ge Medical Systems Information Technologies, Inc.	MAC 7 Resting ECG Analysis System
2025-12-22	K252361	Accurkardia, Inc.	AccurECG Analysis System (v2.0)
2025-11-10	K252474	Withings	Withings BeamO (SCT02)
2025-08-06	K250569	Philips France Commercial	Cardiologs Holter Platform
2025-07-10	K243252	Zbeats, Inc.	ZBPro Diagnostic
2025-04-03	K243305	Masimo Corporation	Masimo W1
2025-01-16	K241217	Inmedix, Inc.	CloudHRV System (100-01-001)
2024-12-17	K241556	Philips Medizin Systeme Böblingen GmbH	Cardiac Workstation (5000); Cardiac Workstation (7000)
2024-08-08	K240229	Masimo Corporation	Masimo W1
2024-06-20	K232161	Medicalgorithmics S.A.	DeepRhythm Platform
2024-06-12	K233266	Mediblu Medical, LLC	MEDIBLU ECG SYSTEM
2024-06-07	K232816	Shenzhen LE Medical Technology Co., Ltd.	Electrocardiograph, model: ECG301
2024-06-07	K232035	AliveCor, Inc.	Impala
2024-05-02	K232445	Cardiacsense	CSF-4 (CSF-4)
2024-04-05	K232823	Amcg Co., Ltd.	MCG-S (AM1000)
2023-12-15	K231160	Bionet Co., Ltd.	Cardio Q50, Cardio Q70
2023-11-21	K230834	Trismed Co., Ltd.	CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
2023-11-17	K232974	Ekgenius, LLC	EKGenius Smart System
2023-11-17	K232512	Masimo Corporation	Masimo W1
2023-11-09	K231150	Bionet Co., Ltd.	Cardio P1
2023-08-23	K230812	Withings	Withings Scan Monitor 2.0
2023-07-28	K223670	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.	MESI mTablet ECG Diagnostic System, MESI mTablet ECG
2023-07-28	K222902	Edan Instruments, Inc.	Electrocardiograph: SE-1200 Pro and SE-1201 Pro