MSX · System, Network And Communication, Physiological Monitors

Device class

Class II

Regulation 870.2300

Total clearances

2020-05-11 → 2026-08-13

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.2300

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
Current Health , Ltd.	3	0	2023-08-24
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	3	0	2025-07-31
Corsano Health B.V.	2	1	2026-07-26
Biofourmis Singapore Pte., Ltd.	2	0	2024-05-09
Draeger Medical Systems, Inc.	2	0	2024-07-12
Zyter, Inc.	1	0	2022-02-11
Spire, Inc. D/B/A Spire Health	1	0	2020-06-05
Taiwan Aulisa Medical Devices Technologies, Inc.	1	0	2020-10-30
Boxview, LLC	1	0	2020-10-30
Philips Medizin Systeme Böblingen GmbH	1	1	2026-03-30
Hinlab Sas	1	0	2024-11-14
Nihon Kohden Corporation	1	0	2023-07-31
Visicu, Inc.	1	0	2022-06-03
Alertwatch, Inc.	1	0	2021-09-10
Hill-Rom, Inc.	1	1	2026-08-13
Tigerconnect	1	1	2025-09-30
Nihon Kohden Digital Health Solutions, LLC	1	0	2025-06-05
Critical Alert	1	0	2020-05-11
Airstrip Technologies, Inc.	1	0	2021-12-09
Sibel Health, Inc.	1	0	2025-01-08

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	—	Medium	CPT for physiological monitoring system setup/interpretation; context-dependent
99354	CPT	—	Low	Possible use in remote patient monitoring context

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-13	K260211	Hill-Rom, Inc.	Dashboard (P007000)
2026-07-26	K261367	Corsano Health B.V.	Corsano CardioWatch 287-2 System
2026-03-30	K253654	Philips Medizin Systeme Böblingen GmbH	IntelliVue Measurement Rack 6000 (867317)
2025-09-30	K243270	Tigerconnect	TigerConnect Alarm Management
2025-07-31	K242728	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision Central Monitoring System
2025-06-05	K242750	Nihon Kohden Digital Health Solutions, LLC	Central Station
2025-01-08	K242842	Sibel Health, Inc.	ANNE View, Central Hub
2024-11-14	K241397	Hinlab Sas	Hinscope
2024-07-12	K233834	Draeger Medical Systems, Inc.	Infinity Gateway Suite
2024-05-09	K233418	Biofourmis Singapore Pte., Ltd.	Biofourmis Everion+ (G2)
2024-03-22	K232548	Corsano Health B.V.	Corsano CardioWatch 287-2 System
2023-08-24	K231506	Current Health , Ltd.	Current Health System
2023-07-31	K223567	Nihon Kohden Corporation	CNS-2101 Central Monitor
2023-02-23	K213863	Biofourmis Singapore Pte., Ltd.	Everion+ System
2022-11-01	K222550	Current Health , Ltd.	Current Health System
2022-06-07	K203579	Draeger Medical Systems, Inc.	Infinity Gateway Suite
2022-06-03	K211046	Visicu, Inc.	eCareManager 4.5
2022-06-01	K220058	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision Central Monitoring System
2022-02-11	K212622	Zyter, Inc.	Zyter RPM
2021-12-09	K211949	Airstrip Technologies, Inc.	AirStrip ONE Web Client with Alarm Communication Management (ACM)
2021-09-10	K210160	Alertwatch, Inc.	AlertWatch:AC
2021-09-03	K210133	Current Health	Current Health Monitoring System Gen 2 (G2)
2020-10-30	K202497	Taiwan Aulisa Medical Devices Technologies, Inc.	Aulisa Multiple Patient Digital Vital Sign Monitoring System
2020-10-30	K193421	Boxview, LLC	Smart Alarm Interface
2020-06-05	K192952	Spire, Inc. D/B/A Spire Health	Spire Health Remote Patient Monitoring System