Chrysalis Intelligence · Product Codes · MXD

MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Cardiovascular · 21 clearances · 5 unique sponsors

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Device class
Class II
Regulation 870.1025
Total clearances
21
2020-04-23 → 2026-05-01
Last 12 months
4
Unique sponsors
5
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1025
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medtronic, Inc. 10 0 2024-03-28
Biotronik, Inc. 5 1 2026-05-01
Boston Scientific Corporation 4 1 2025-09-12
ABBOTT MEDICAL 1 1 2025-12-18
Abbott 1 1 2025-09-17
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
93285 CPT — Medium Implantable cardiac event recorder insertion with arrhythmia detection
93287 CPT — Medium Interrogation and data download for implantable recorder with arrhythmia detection
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-01 K261074 Biotronik, Inc. BIOMONITOR IV (471155)
2025-12-18 K253516 ABBOTT MEDICAL Assert-IQ (DM5100)
2025-09-17 K251221 Abbott Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
2025-09-12 K252593 Boston Scientific Corporation LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
2024-03-28 K240693 Medtronic, Inc. LINQ II™ Insertable Cardiac Monitor (ICM)
2023-12-06 K233562 Medtronic, Inc. LINQ II Insertable Cardiac Monitor
2023-10-31 K233320 Medtronic, Inc. LINQ II™ Insertable Cardiac Monitor (LNQ22)
2023-08-19 K231328 Boston Scientific Corp LUX-Dx II (M302); LUX-Dx II+ (M312)
2023-05-19 K230375 Biotronik, Inc. BIOMONITOR IV
2023-04-26 K230553 Medtronic, Inc. LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
2023-04-05 K223630 Medtronic, Inc. Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
2022-08-25 K221962 Medtronic, Inc. LINQ II Insertable Cardiac Monitor
2022-07-27 K221856 Biotronik, Inc. BIOMONITOR IIIm, BIOMONITOR III
2021-07-22 K212008 Medtronic, Inc. Reveal LINQ Insertable Cardiac Monitor
2021-06-11 K210484 Medtronic, Inc. LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
2021-05-28 K211304 Medtronic, Inc. LINQ II Insertable Cardiac Monitor
2021-05-25 K210608 Boston Scientific Corporation LUX-Dx Insertable Cardiac Monitor
2020-12-08 K201865 Biotronik, Inc. Biomonitor III, Biomonitor IIIm
2020-07-03 K200795 Medtronic, Inc. LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
2020-06-26 K193473 Boston Scientific Corporation LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
2020-04-23 K200444 Biotronik, Inc. Biomonitor III, Biomonitor IIIm
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence