# KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

- Device class: 2; regulation: 21 CFR 880.6850; FDA's rule: 510(k) required
- FDA decisions: 284
- 510(k) review time 2021–2025: median 132 days (middle half 89–249)
- Recalls: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 10
- 2018: 15
- 2019: 18
- 2020: 14
- 2021: 18
- 2022: 11
- 2023: 10
- 2024: 8
- 2025: 11
- 2026: 9

## Most-cited predicates
- K012105: Polyvac Surgical Instrument Delivery System (2002), cited by 21
- K033222: Olympus Sterilization Trays (2004), cited by 8
- K090562: Smith & Nephew Instrument Trays (2009), cited by 7
- K040223: Polyvac Instrument Delivery System (2004), cited by 7
- K180791: Straumann BLX Surgical Cassette (2018), cited by 5
- K133015: Instru-Safe Instrument Protection System (2014), cited by 5
- K142519: InterActive Complete Surgical Tray (2015), cited by 5
- K980065: C/T Med-Systems Cassette System (1998), cited by 5
- K051242: Winner Self Seal Sterilization Pouch (2005), cited by 5
- K073551: Smith & Nephew Instrument Trays (2008), cited by 5

Source page: https://510kreport.com/product-code/KCT
Data by year (CSV): https://510kreport.com/product-code/KCT.csv