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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 / February 2026 / K252672

510(k) cleared

CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)

Casebioscience, Inc. · Feb 20, 2026 · K252672

FDA cleared the CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) from Casebioscience, Inc. on Feb 20, 2026 under K252672, a traditional 510(k). The device falls under product code MQL, Media, Reproductive, regulated at 21 CFR 884.6180 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 25, 2025. The decision came 179 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 Casebioscience, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252672?

K252672 is the FDA 510(k) for CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5), submitted by Casebioscience, Inc.. FDA's decision date was Feb 20, 2026, under product code MQL (Media, Reproductive).

Who makes the CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)?

Casebioscience, Inc., based in Guelph, is the applicant of record for K252672.

How long did the K252672 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Feb 20, 2026, 179 days later.

← All decisions in February 2026