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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 / June 2026 / K253316

510(k) cleared

PhAST instrument and PhAST Blood Culture Gram-negative Panel

Phast Corp. · Jun 26, 2026 · K253316

FDA cleared the PhAST instrument and PhAST Blood Culture Gram-negative Panel from Phast Corp. on Jun 26, 2026 under K253316, 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 Sep 30, 2025. The decision came 269 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 Phast Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253316?

K253316 is the FDA 510(k) for PhAST instrument and PhAST Blood Culture Gram-negative Panel, submitted by Phast Corp.. FDA's decision date was Jun 26, 2026, under product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples).

Who makes the PhAST instrument and PhAST Blood Culture Gram-negative Panel?

Phast Corp., based in Boston, MA, is the applicant of record for K253316.

How long did the K253316 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jun 26, 2026, 269 days later.

← All decisions in June 2026