Atlas FDA

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

FDA 510(k) clearance K251221 · decided 2025-09-17

Clearance details

K-number
K251221
Device name
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
Applicant
Abbott
Decision
Substantially Equivalent
Date received
2025-04-21
Decision date
2025-09-17
Days to decision
149 days
Clearance type
Traditional
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 (DM5100) (K253516)ABBOTT MEDICAL2025-12-18
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
CentriMag™ Circulatory Support System (P170038/S025)Abbott2025-12-01
CentriMag Circulatory Support System (P170038/S023)Abbott2025-09-29
CentriMag™ Circulatory Support System (P170038/S026)Abbott2025-08-21
CentriMag Circulatory Support System (P170038/S024)Abbott2025-06-02
CentriMag™ Circulatory Support System (P170038/S017)Abbott2025-02-04
CentriMag Circulatory Support System (P170038/S022)Abbott2024-11-05
CentriMag Circulatory Support System (P170038/S021)Abbott2024-11-01
CentriMag™ Circulatory Support System (P170038/S020)Abbott2024-09-25