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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 / October 2025 / K251875

510(k) cleared

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

Affinity Biosensors, LLC · Oct 27, 2025 · K251875

FDA cleared the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system from Affinity Biosensors, LLC on Oct 27, 2025 under K251875, a traditional 510(k). The device falls under product code SAN, Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, regulated at 21 CFR 866.1650 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 18, 2025. The decision came 131 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 Affinity Biosensors, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251875?

K251875 is the FDA 510(k) for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system, submitted by Affinity Biosensors, LLC. FDA's decision date was Oct 27, 2025, under product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples).

Who makes the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

Affinity Biosensors, LLC, based in Santa Barbara, CA, is the applicant of record for K251875.

How long did the K251875 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Oct 27, 2025, 131 days later.

← All decisions in October 2025