# K023658: Sterilization Cases and Trays

- Pathway: 510(k) (Traditional)
- Applicant: Carr Metal Products, Inc.
- Decided: Mar 25, 2003 after 145 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: 4 generations back to K844002 (1984). 6 ancestors in all.
43 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980065: C/T Med-Systems Cassette System, C/T Med System, Ltd. (1998) Summary page 1.
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002)

## Most influential descendants
- K052992: Conmed Linvatec Instrument Sterilization Tray (2006), 42 descendants of its own
- 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

## Indications for use
Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 "C for a 4-minute minimum plus a minimum of 15 minutes drying time.

Source page: https://510kreport.com/device/K023658
Methodology: https://510kreport.com/methodology