Assert-IQ (DM5100)
FDA 510(k) K253516 · Abbott Medical
510(k) numberK253516
Submission
- Device name
- Assert-IQ (DM5100)
- Applicant
- Abbott Medical
Sylmar, CA, US - Received
- November 12, 2025
- Decision date
- December 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code MXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | Medtronic, Inc. | 08/28/2026SE |
| K261074 | Biomonitor IV (471155)MXD · Special | Biotronik, Inc. | 05/01/2026SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | Abbott | 09/17/2025SE |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD · Special | Boston Scientific Corporation | 09/12/2025SE |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM)MXD · Special | Medtronic, Inc. | 03/28/2024SE |
| K233562 | LINQ II Insertable Cardiac MonitorMXD · Special | Medtronic, Inc. | 12/06/2023SE |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22)MXD · Special | Medtronic, Inc. | 10/31/2023SE |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312)MXD · Traditional | Boston Scientific Corp | 08/19/2023SE |
| K230375 | Biomonitor IVMXD · Traditional | Biotronik, Inc. | 05/19/2023SE |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMXD · Traditional | Medtronic, Inc. | 04/26/2023SE |
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Questions and answers
When was Assert-IQ (DM5100) cleared by the FDA?
Assert-IQ (DM5100) (K253516) received a 510(k) decision of Substantially Equivalent on December 18, 2025, 36 days after the submission was received.
What is the product code of K253516?
The FDA product code is MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), a Class II (moderate risk) device regulated under 21 CFR 870.1025.