# K120117: Codman Quad-Lock Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Apr 16, 2012 after 90 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871202 (1987). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K092437: Codman Sterilization Containers, Codman & Shurtleff, Inc. (2010) Summary page 1.

## Most influential descendants
- K152111: Symmetry Surgical Quad-Lock Container System (2016), 0 descendants of its own

## Recalls of this device
- Dec 5, 2013 · Class II · Z-0833-2014: The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.

## Indications for use
The CODMAN QUAD-LOCK Sterilization Container System is indicated for use by hospitals and by health care facilities to: *organize and protect stainless steel, aluminum, titanium, plastic and silicone 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, titanium, plastic and silicone surgical instruments. Lumen inner diameter: 3mm or larger Lumen length: 400mm or less (medium and large size containers) 250mm 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 QUAD-LOCK Sterilization Container, the recommended maximum combined weight of the single container, lid, basket/tray and basket/tray contents is 25 lb. (111.3 kg). Table 1 Sterilization Parameters Cycle Type: Prevacuum Temperature: 13200 Exposure Time: 4 minutes Dry Time: 30 minutes The Codman® Quad-Lock™ Sterilization Container Systems can be stacked during sterilization with up to three containers.

Source page: https://510kreport.com/device/K120117
Methodology: https://510kreport.com/methodology