# K052992: Conmed Linvatec Instrument Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: Oct 16, 2006 after 356 days
- Product code: FRG (Wrap, Sterilization)
- 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: 5 generations back to K844002 (1984). 8 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 2.
- K023658: Sterilization Cases and Trays, Carr Metal Products, Inc. (2003) Summary page 2.
- K944025: Surgical Instrument Tray, Riley Medical, Inc. (1994) Summary page 2.

## Most influential descendants
- K142519: InterActive Complete Surgical Tray (2015), 30 descendants of its own
- K160730: Instrument kits (2017), 20 descendants of its own
- K171713: Neodent Instrument Kits (2018), 18 descendants of its own
- K182865: Neodent Instruments Kits (2019), 13 descendants of its own
- K070769: VHP 136 Tray (2007), 10 descendants of its own

## Indications for use
The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses. The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization. The validated sterilization cycles are provided in Table II. The cycles were validated using Kimguard (Kimberly Clark). The sterilization exposure times are extended. Please refer to Table 2 for cycle tines. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays. The sterilized contents are for immediate use and should not be stored for any duration. The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc. Table 1lists the trays included in this submission.

Source page: https://510kreport.com/device/K052992
Methodology: https://510kreport.com/methodology