# K141854: Instrument Cassette (EFCCL1-F)

- Pathway: 510(k) (Traditional)
- Applicant: Osung Mnd Co., Ltd.
- Decided: Oct 29, 2015 after 477 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: 1 generation back to K101653 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101653: Miltex Thompson Cassettes; Miltex Surgical Cassettes, Miltex, Inc. (2010) Summary page 4.

## Indications for use
OSUNG INSTRUMENT CASSETTE (EFCCL1-F) is intended to hold instruments and accessories during storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap in order to maintain sterility. This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility. Validated sterilization parameters: Cycle Type Temperature Exposure Time Dry Time Gravity Steam 132℃ (270°F) 15 minutes 30 minutes

Source page: https://510kreport.com/device/K141854
Methodology: https://510kreport.com/methodology