WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252854

510(k) cleared

SteriTite Container System with MediTray Products

Case Medical, Inc. · Jun 3, 2026 · K252854

FDA cleared the SteriTite Container System with MediTray Products from Case Medical, Inc. on Jun 3, 2026 under K252854, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 8, 2025. The decision came 268 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 Case Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252854?

K252854 is the FDA 510(k) for SteriTite Container System with MediTray Products, submitted by Case Medical, Inc.. FDA's decision date was Jun 3, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the SteriTite Container System with MediTray Products?

Case Medical, Inc., based in Bloomfield, NJ, is the applicant of record for K252854.

How long did the K252854 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Jun 3, 2026, 268 days later.

← All decisions in June 2026