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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K253516

510(k) cleared

Assert-IQ (DM5100)

ABBOTT MEDICAL · Dec 18, 2025 · K253516

FDA cleared the Assert-IQ (DM5100) from ABBOTT MEDICAL on Dec 18, 2025 under K253516, a special 510(k). The device falls under product code MXD, Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 12, 2025. The decision came 36 days later, inside the 90 FDA-day goal for a 510(k).

ABBOTT MEDICAL has 8 other decisions in the tracker over the last 12 months: K262006 (EnSite X EP System), K261825 (Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter), K261631 (Amplatzer TorqVue Exchange System), K253459 (OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)).

Questions & Answers

What did FDA clear under K253516?

K253516 is the FDA 510(k) for Assert-IQ (DM5100), submitted by ABBOTT MEDICAL. FDA's decision date was Dec 18, 2025, under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)).

Who makes the Assert-IQ (DM5100)?

ABBOTT MEDICAL, based in Sylmar, CA, is the applicant of record for K253516.

How long did the K253516 review take?

FDA received the submission on Nov 12, 2025 and issued its decision on Dec 18, 2025, 36 days later.

← All decisions in December 2025