Atlas FDA

Assert-IQ (DM5100)

FDA 510(k) clearance K253516 · decided 2025-12-18

Clearance details

K-number
K253516
Device name
Assert-IQ (DM5100)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2025-11-12
Decision date
2025-12-18
Days to decision
36 days
Clearance type
Special
Product code
MXD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Sylmar, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BIOMONITOR IV (471155) (K261074)Biotronik, Inc.2026-05-01
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221)Abbott2025-09-17
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (K252593)Boston Scientific Corporation2025-09-12
LINQ II™ Insertable Cardiac Monitor (ICM) (K240693)Medtronic, Inc.2024-03-28
LINQ II Insertable Cardiac Monitor (K233562)Medtronic, Inc.2023-12-06
LINQ II™ Insertable Cardiac Monitor (LNQ22) (K233320)Medtronic, Inc.2023-10-31
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
BIOMONITOR IV (K230375)Biotronik, Inc.2023-05-19
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (K230553)Medtronic, Inc.2023-04-26
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System (K223630)Medtronic, Inc.2023-04-05
LINQ II Insertable Cardiac Monitor (K221962)Medtronic, Inc.2022-08-25
BIOMONITOR IIIm, BIOMONITOR III (K221856)Biotronik, Inc.2022-07-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092)ABBOTT MEDICAL2025-12-23
Proclaim™ Spinal Cord Stimulation (SCS) System (P010032/S246)ABBOTT MEDICAL2025-12-23
Infinity™ Deep Brain Stimulation (DBS) System (P140009/S127)ABBOTT MEDICAL2025-12-23
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S014)ABBOTT MEDICAL2025-12-23
Volt™ PFA System (P250022)ABBOTT MEDICAL2025-12-19
HeartMate II™ Left Ventricular Assist System (P060040/S122)ABBOTT MEDICAL2025-12-17
HeartMate 3™ Left Ventricular Assist System (P160054/S116)ABBOTT MEDICAL2025-12-17
Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09