# K092551: Smith & Nephew Instrument Trays

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Sep 14, 2010 after 390 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.
No later device cites it as a predicate yet.
0 of 11 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 2.
- K090562: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 2.
- K091627: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 2.

## Indications for use
Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAYS are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument trays are suitable for use in a prevacuum steam method. They are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.

Source page: https://510kreport.com/device/K092551
Methodology: https://510kreport.com/methodology