WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / July 2026 / K253463

510(k) cleared

ILR ECG Analyzer (IM007)

Implicity, Inc. · Jul 2, 2026 · K253463

FDA cleared the ILR ECG Analyzer (IM007) from Implicity, Inc. on Jul 2, 2026 under K253463, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 8, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Implicity, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253463?

K253463 is the FDA 510(k) for ILR ECG Analyzer (IM007), submitted by Implicity, Inc.. FDA's decision date was Jul 2, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the ILR ECG Analyzer (IM007)?

Implicity, Inc., based in Cambridge, MA, is the applicant of record for K253463.

How long did the K253463 review take?

FDA received the submission on Oct 8, 2025 and issued its decision on Jul 2, 2026, 267 days later.

← All decisions in July 2026