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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 / November 2025 / K252762

510(k) cleared

HALO AP Dx

Indica Labs, LLC · Nov 25, 2025 · K252762

FDA cleared the HALO AP Dx from Indica Labs, LLC on Nov 25, 2025 under K252762, a traditional 510(k). The device falls under product code QKQ, Digital Pathology Image Viewing And Management Software, regulated at 21 CFR 864.3700 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Aug 29, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Indica Labs, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252762?

K252762 is the FDA 510(k) for HALO AP Dx, submitted by Indica Labs, LLC. FDA's decision date was Nov 25, 2025, under product code QKQ (Digital Pathology Image Viewing And Management Software).

Who makes the HALO AP Dx?

Indica Labs, LLC, based in Albuquerque, NM, is the applicant of record for K252762.

How long did the K252762 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Nov 25, 2025, 88 days later.

← All decisions in November 2025