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FDA 510(k)

ONE TRAY® Sealed Sterilization Container System

K-Number: K250029 · 2025-05-01

ApplicantInnovative Sterilization Technologies
Decision Date2025-05-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ONE TRAY® Sealed Sterilization Container System is a medical device manufactured by Innovative Sterilization Technologies. It received FDA 510(k) clearance on 2025-05-01 under approval number K250029. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE TRAY® Sealed Sterilization Container System?

ONE TRAY® Sealed Sterilization Container System is a medical device that received FDA 510(k) clearance on 2025-05-01. It is manufactured by Innovative Sterilization Technologies. The 510(k) number is K250029.

When was ONE TRAY® Sealed Sterilization Container System approved by the FDA?

ONE TRAY® Sealed Sterilization Container System received FDA 510(k) clearance on 2025-05-01, under approval number K250029.

What company makes ONE TRAY® Sealed Sterilization Container System?

ONE TRAY® Sealed Sterilization Container System is manufactured by Innovative Sterilization Technologies.

What is the FDA product code for ONE TRAY® Sealed Sterilization Container System?

The FDA product code for ONE TRAY® Sealed Sterilization Container System is KCT.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT04610294 Operating Room Air Filtration/Sterilization ACTIVE_NOT_RECRUITING

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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