# K092437: Codman Sterilization Containers

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Mar 25, 2010 after 230 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: 3 generations back to K871202 (1987). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072563: Miltex Rigid Container Systems, Miltex, Inc. (2008) Summary page 1.

## Most influential descendants
- K120117: Codman Quad-Lock Sterilization Container System (2012), 1 descendant of its own
- K152111: Symmetry Surgical Quad-Lock Container System (2016), 0 descendants of its own

## Indications for use
The CODMAN Sterilization Container System is indicated for use by hospitals and by health care facilities to: organize and protect stainless steel, aluminum, and titanium general surgical instruments that will be sterilized allow sterilization of the contained instruments by prevacuum steam sterilization (validated, parameters shown in Table 1) maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, and titanium general surgical instruments. The system is intended for use with lumen instruments as follows: Lumen inner diameter 3 mm or larger Lumen length 400 mm or less (medium and large size containers) 250 mm or less (small size containers) Quantity Up to 4 lumen instruments per container The system is not intended for the sterilization of endoscopes. For effective sterilization and drying of any size CODMAN Sterilization Container, the recommended maximum combined weight of the single container, lid, basket and basket contents is 25 lb. (11.3 kg). Please refer to Appendix A for a table of validated configurations of lids, bottoms, safety covers, and accessories. Table 1 Sterilization Parameters Cycle Type: Prevacuum; Temperature: 132 °C; Exposure Time: 4 minutes; Dry Time: 30 minutes

Source page: https://510kreport.com/device/K092437
Methodology: https://510kreport.com/methodology