Data / Medical devices / United States / Innovative Sterilization Techn
Innovative Sterilization Techn: FDA-registered device maker in Dayton, OH, United States, 6 510(k) clearances
Innovative Sterilization Techn is registered with the FDA (registration 3010772758) in Dayton, OH, United States. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated May 1, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010772758
- Address
- 7625 Paragon RD Ste A, Dayton, OH, United States, 45459
- Owner or operator
- Innovative Sterilization Technologies LLC (10046120)
- Roles
- Manufacturer
- First device listed
- February 5, 2014
- Registered through
- 2026
- Brand names listed
- EZ TRAX Persona Knee Containment Device, EZ TRAX Stryker Mako Total Knee Containment Device, EZ TRAX Zimmer G7 Acetabular Taperloc Complete Hip System Containment Device, EZ-TRAX Containment Device, ONE TRAY, ONE TRAY Sealed Sterilization Container System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2025 | K250029 | ONE TRAY® Sealed Sterilization Container System | KCT | Substantially Equivalent | Innovative Sterilization Technologies | accessdata.fda.gov |
| December 28, 2021 | K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | KCT | Substantially Equivalent | K1 Medical, LLC | accessdata.fda.gov |
| July 1, 2021 | K211007 | EZ-TRAXTM Persona Knee Containment Device | KCT | Substantially Equivalent | K1 Medical, LLC | accessdata.fda.gov |
| December 2, 2020 | K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | KCT | Substantially Equivalent | K1 Medical, LLC | accessdata.fda.gov |
| December 23, 2019 | K192487 | EZ-TRAX Containment Device | KCT | Substantially Equivalent | K1 Medical, LLC | accessdata.fda.gov |
| March 13, 2006 | K052567 | ONE TRAY SEALED STERILIZATION CONTAINER | KCT | Substantially Equivalent | Sterile Containment Technology, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 3, 2014 | 72011 | Class II | Terminated | OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices | The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F. | accessdata.fda.gov |
Compare with other makers
Updated May 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.