Chrysalis Intelligence · Product Codes · MHX

MHX · Unclassified

62 clearances · 18 unique sponsors

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Device class
—
Regulation —
Total clearances
62
2020-01-21 → 2026-08-06
Last 12 months
14
Unique sponsors
18
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
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. 8 1 2026-08-06
Philips Medizin Systeme Boeblingen GmbH 7 2 2026-02-06
Ge Medical Systems Information Technologies, Inc. 7 1 2026-07-24
GE Healthcare Finland Oy 7 0 2023-04-06
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 6 2 2026-05-20
Draeger Medical Systems, Inc. 5 0 2024-08-01
Philips Medizin Systeme Böblingen GmbH 5 2 2025-11-10
Masimo Corporation 3 1 2026-06-04
Caf Medical Solutions, Inc. 2 0 2022-08-10
Shanghai Draeger Medical Instrument Co., Ltd. 2 2 2026-04-24
Shenzhen Comen Medical Instruments Co.,Ltd 2 1 2025-12-17
AliveCor, Inc. 2 1 2026-01-09
Nihon Kohden Digital Health Solutions, Inc. 1 0 2022-07-29
Remote Diagnostic Technologies Limited 1 0 2020-09-18
Global Instrumentation, LLC 1 1 2026-05-29
Schiller AG 1 0 2023-07-06
GE Healthcare 1 0 2020-03-29
Nihon Kohden Corporation 1 0 2021-07-16
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 — Medium CPT for electrocardiogram; physiological monitor with arrhythmia detection billing varies by configuration
93041 CPT — Medium CPT for rhythm strip with interpretation; cardiac monitoring code for arrhythmia detection
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-06 K251508 Edan Instruments, Inc. Telemetry Monitor (iT30, iT50)
2026-07-24 K253277 Ge Medical Systems Information Technologies, Inc. Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
2026-06-04 K254209 Masimo Corporation Radius VSM and Accessories
2026-05-29 K252840 Global Instrumentation, LLC M12 Telemetry System
2026-05-20 K260098 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
2026-04-24 K250349 Shanghai Draeger Medical Instrument Co., Ltd. Vista CMS
2026-04-16 K253170 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
2026-04-10 K252250 Shanghai Draeger Medical Instrument Co., Ltd. Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
2026-02-06 K252726 Philips Medizin Systeme Boeblingen GmbH IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
2026-01-09 K252589 AliveCor, Inc. Corvair Monza
2025-12-17 K250854 Shenzhen Comen Medical Instruments Co.,Ltd Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
2025-11-10 K251702 Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
2025-10-17 K251146 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient monitors MX400, MX450, MX500, MX550
2025-09-02 K250453 Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
2025-07-29 K250179 Edan Instruments, Inc. Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
2025-07-09 K242562 Ge Medical Systems Information Technologies, Inc. Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
2025-05-29 K250757 Masimo Corporation Radius VSM and Accessories
2025-05-05 K242962 Philips Medizin Systeme Böblingen GmbH Telemetry Monitor 5500 Release 4.0 (867232)
2024-08-01 K240312 Draeger Medical Systems, Inc. Infinity CentralStation Wide
2024-06-28 K240320 Edan Instruments, Inc. Patient Monitor (RespArray)
2024-06-07 K231010 AliveCor, Inc. Corvair
2024-04-19 K232962 Edan Instruments, Inc. Patient Monitor (iX10, iX12, iX15)
2024-02-05 K232694 Edan Instruments, Inc. Central Monitoring System (MFM-CMS)
2023-12-19 K231671 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
2023-11-22 K230604 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence