Assert-IQ (DM5100)
K-Number: K253516 · 2025-12-18
ApplicantABBOTT MEDICAL
Decision Date2025-12-18
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Assert-IQ (DM5100) is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-12-18 under approval number K253516. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Assert-IQ (DM5100)?
Assert-IQ (DM5100) is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K253516.
When was Assert-IQ (DM5100) approved by the FDA?
Assert-IQ (DM5100) received FDA 510(k) clearance on 2025-12-18, under approval number K253516.
What company makes Assert-IQ (DM5100)?
Assert-IQ (DM5100) is manufactured by ABBOTT MEDICAL.
What is the FDA product code for Assert-IQ (DM5100)?
The FDA product code for Assert-IQ (DM5100) is MXD.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.