# K091627: Smith & Nephew Instrument Trays

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 2, 2009 after 29 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: 6 generations back to K844002 (1984). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 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.

## Most influential descendants
- K102122: Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428 (2010), 1 descendant of its own
- K203177: Sterisystem Dry-Base Instrument Tray (2022), 0 descendants of its own
- K102544: Smith & Nephew Hip Arthroscopy Repair Instrument Tray (2011), 0 descendants of its own
- K092551: Smith & Nephew Instrument Trays (2010), 0 descendants of its own

## Indications for use
Smith & Nephew instrument 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 and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Validated Sterilization Parameters: Method Temperature Exposure Time Drying Time Pre-vacuum steam 132C (270F) 4 minutes 30 minutes High Temperature Gravity Steam 132C (270F) 15 minutes 70 minutes

Source page: https://510kreport.com/device/K091627
Methodology: https://510kreport.com/methodology