# K112090: Bahadir Sterilization Trays

- Pathway: 510(k) (Abbreviated)
- Applicant: Bahadir USA Corp.
- Decided: Jun 7, 2012 after 322 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: 6 generations back to K991023 (2000). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102146: Bahadir Sterilization Trays, Bahadir USA Corp. (2010) Summary page 1.

## Most influential descendants
- K131407: Bahadir Sterilization Trays (2014), 1 descendant of its own
- K233578: Bahadir Sterilization Containers (2024), 0 descendants of its own

## Recalls of this device
- Jul 30, 2014 · Class II · Z-2624-2014: Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.

## Indications for use
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow Sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container. The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes. The devices (natural aluminum color containers and lids) subject to this submission are as follows: Full Size Y1 11.10W %/SizeY211.1 OW %/Size Y31l1-1OW Full Size Y1 11.13W %/SizeY2ll.13W 1/2Size Y311.13W Full SizeY1lll.1 5W %Size Y211.15W 1/Size Y3ll.15W Full Size Y1 11.20W %ASizeY3ll.20W Full Size Y1 1.26W 'A Size Y31 1.26W Full Size Y1 1O.62W Full Size Y1 10.68W Full Size Y1 11.62W Full Size Y1 11.68W (Full Size Max Load Wt. 24.75 lbs (% Max Load Wt. 12.5 lbs ('A Size Max Load Wt. 9.25 lbs including basket & instruments) including basket & instruments) including basket & instruments) Lumen Size min 1mm diameter Lumen Size min 1mm diameter Lumen size min 1mm diameter X 300mm length X 200mm length X 200mm length

Source page: https://510kreport.com/device/K112090
Methodology: https://510kreport.com/methodology