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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovative Sterilization Technologies. It received FDA 510(k) clearance on 2025-05-01 under 510(k) 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. The listed applicant is Innovative Sterilization Technologies. The 510(k) number is K250029.

When did ONE TRAY® Sealed Sterilization Container System receive FDA 510(k) clearance?

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

Who is the listed applicant for ONE TRAY® Sealed Sterilization Container System?

The FDA 510(k) record lists Innovative Sterilization Technologies as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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