# K102146: Bahadir Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Bahadir USA Corp.
- Decided: Nov 18, 2010 after 111 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: 5 generations back to K991023 (2000). 11 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K050570: Miltex Rigid Sterilization Container System, Miltex, Inc. (2005) Summary page 1.
- K072563: Miltex Rigid Container Systems, Miltex, Inc. (2008) Summary page 4.
- K091720: Sklarlite Rigid Sterilization Container System, Sklar Corp. (2010) Summary page 1.

## Most influential descendants
- K112090: Bahadir Sterilization Trays (2012), 2 descendants of its own
- 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 1/1 Y110.20 Full Size 1/1 Y110.15 Full Size 1/1 Y110.13 Full Size 1/1 Y110.10 ¾ Size Y210.10 ¾ Size Y210.15 ¾ Size Y210.13 ½ Size Y310.20 ½ Size Y310.15 ½ Size Y310.13 ½ Size Y310.10 The maximum load weight is 24.75 lbs for full size, 12.5 lbs for ¾ size, and 9.25 lbs for ½ size. The sterilization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments. The subject trays are not validated for use with lumened devices, air driven instruments, power systems, or cannulized instruments.

Source page: https://510kreport.com/device/K102146
Methodology: https://510kreport.com/methodology