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 / K253187

510(k) cleared

SteriBest® Sterilization Tray System

Mastel Surgical · Jun 18, 2026 · K253187

FDA cleared the SteriBest® Sterilization Tray System from Mastel Surgical on Jun 18, 2026 under K253187, 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 26, 2025. The decision came 265 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 Mastel Surgical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253187?

K253187 is the FDA 510(k) for SteriBest® Sterilization Tray System, submitted by Mastel Surgical. FDA's decision date was Jun 18, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the SteriBest® Sterilization Tray System?

Mastel Surgical, based in Rapid City, SD, is the applicant of record for K253187.

How long did the K253187 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 18, 2026, 265 days later.

← All decisions in June 2026