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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 / K252627

510(k) cleared

Lyme-ID IgG Test; Bio-ID800

Inanovate, Inc. · Nov 14, 2025 · K252627

FDA cleared the Lyme-ID IgG Test; Bio-ID800 from Inanovate, Inc. on Nov 14, 2025 under K252627, a traditional 510(k). The device falls under product code LSR, Reagent, Borrelia Serological Reagent, regulated at 21 CFR 866.3830 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Aug 20, 2025. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252627?

K252627 is the FDA 510(k) for Lyme-ID IgG Test; Bio-ID800, submitted by Inanovate, Inc.. FDA's decision date was Nov 14, 2025, under product code LSR (Reagent, Borrelia Serological Reagent).

Who makes the Lyme-ID IgG Test; Bio-ID800?

Inanovate, Inc., based in Sioux Falls, SD, is the applicant of record for K252627.

How long did the K252627 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Nov 14, 2025, 86 days later.

← All decisions in November 2025