FDA Product Code KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Maintaining sterility of surgical instruments between sterilization and use is as important as the sterilization process itself. FDA product code KCT covers sterilization wrap containers, trays, and cassettes.
These rigid or semi-rigid systems protect sterilized instruments from contamination during storage and transport to the point of use. Unlike sterilization wraps, rigid containers provide a durable, reusable barrier that maintains sterility for extended periods.
KCT devices are Class II medical devices, regulated under 21 CFR 880.6850 and reviewed by the FDA General Hospital panel.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Dentsply Sirona, Inc. and Dentsply Sirona.
FDA 510(k) Cleared Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Devices (Product Code KCT)
About Product Code KCT - Regulatory Context
510(k) Submission Activity
277 total 510(k) submissions under product code KCT since 1976, with 277 receiving FDA clearance (average review time: 185 days).
Submission volume has remained relatively stable over the observed period, with 19 submissions in the last 24 months.
FDA Review Time
FDA review times for KCT submissions have been consistent, averaging 167 days recently vs 187 days historically.
KCT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →