# K102122: Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 22, 2010 after 116 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K844002 (1984). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073551: Smith & Nephew Instrument Trays, Smith & Nephew Inc., Endoscopy Div. (2008) Summary page 1.
- K090562: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 1.
- K091627: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 1.

## Most influential descendants
- K203177: Sterisystem Dry-Base Instrument Tray (2022), 0 descendants of its own

## Indications for use
Smith & Nephew Multi-Purpose Sterilization trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam sterilization method. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices. Validated Sterilization Parameters: Method Temperature Exposure Time Drying Time Pre-vacuum 132 C 4 minutes 30 minutes steam (270 F)

Source page: https://510kreport.com/device/K102122
Methodology: https://510kreport.com/methodology