# K131407: Bahadir Sterilization Trays - Pathway: 510(k) (Abbreviated) - Applicant: Bahadir USA Corp. - Decided: Aug 12, 2014 after 454 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 K991023 (2000). 15 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 17 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K112090: Bahadir Sterilization Trays, Bahadir USA Corp. (2012) Summary page 6. - K102146: Bahadir Sterilization Trays, Bahadir USA Corp. (2010) Summary page 6. - K053389: Aesculap Sterilcontainer System, Aesculap, Inc. (2006) Summary page 6. - K091720: Sklarlite Rigid Sterilization Container System, Sklar Corp. (2010) Summary page 6. ## Most influential descendants - K233578: Bahadir Sterilization Containers (2024), 0 descendants of its own ## Indications for use Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18” maximum configuration. Containers are marked as to their height to facilitate this process. 3 containers MAXIMUM can be stacked. Stacked containers may not exceed a maximum of 18 inches Immediate Use only intended for non-stacked configurations during the sterilization process. The devices included in this submission are to be used with a pre-vacuum, three pulse standard cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization. The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows: Flat Size Y310.05A Mini Size Y410.04A Dental Size Y510.04A Flat Size Y310.08A Mini Size Y410.07A Dental Size Y510.06A Flat Size Y311.08A Mini Size Y410.10A Dental Size Y510.08A Mini Size Y411.04A Dental Size Y510.10A Mini Size Y411.07A Dental Size Y510.13A Mini Size Y411.10A Dental Size Y511.04A Dental Size Y511.06A Dental Size Y511.08A Dental Size Y511.10A Dental Size Y511.13A Full size Y110.10W ¾ size Y210.10W ½ size Y310.10W Full size Y111.10W ¾ size Y210.13W ½ size Y310.13W Full size Y110.13W ¾ size Y210.15W ½ size Y310.15W Full size Y111.13W ¾ size Y211.10W ½ size Y310.20W Full size Y110.15W ¾ size Y211.13W ½ size Y310.26W Full size Y111.15W ¾ size Y211.15W ½ size Y311.10W Full size Y110.20W ½ size Y311.13W Full size Y111.20W ½ size Y311.15W Full size Y111.26W ½ size Y311.20W Wide size Y110.62W ½ size Y311.26W Wide size Y110.68W Wide size Y111.62W Wide size Y111.68W The Containers have been validated for sterilization of instrument load weights shown below, and may include in this max load weight up to 2 instruments with lumens no smaller than 1 mm in diameter and no longer than 300 mm in length for the Full Size, ¾ Size, and Wide Body Containers, and no smaller than 1 mm in diameter and no longer than 200mm in length for the Half Size, Mini, Flat, & Dental Containers. The maximum load weights for the Sterilization Containers which are the subject of this premarket notification are as follows: Maximum Recommended Load (including basket and contents) LBS. Model Dimensions (mm) 580X280X100 24.75 580X280X135 24.75 1/1 Size 580X280X150 24.75 Container 580X280X200 24.75 580X280X260 24.75 465x280x100 12.5 3/4 Size 465x280x135 12.5 Container 465x280x150 12.5 285x280x100 9.25 1/2 Size 285x280x135 9.25 285x280x150 9.25 Container 285x280x200 9.25 285x280x260 9.25 600x400x120 24.75 Wide Body Container 600x400x180 24.75 285x280x55 9.25 Flat Container 285x280x85 9.25 300x140x40 6.0 Mini 300x140x70 6.0 Container 300x140x100 6.0 310x190x40 9.25 Dental 310x190x65 9.25 Container 310x190x130 9.25 Source page: https://510kreport.com/device/K131407 Methodology: https://510kreport.com/methodology