510(k) K252854

SteriTite Container System with MediTray Products by Case Medical, Inc. — Product Code KCT

K252854 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "SteriTite Container System with MediTray Products". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Case Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2026
Date Received
September 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type