# K141616: Sterilization Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Oticon Medical AB
- Decided: Sep 23, 2014 after 99 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: 4 generations back to K844002 (1984). 6 ancestors in all.
2 later devices descend 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)
- K844002: HU-Friedy Ims Cassette System, Hu-Friedy Mfg. Co., Inc. (1984) Summary page 4.
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K152951: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray (2015), 1 descendant of its own
- K190667: Sonopet iQ Sterilization Tray (2019), 0 descendants of its own

## Indications for use
The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use. The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles: Cycle alt 1 Cycle alt 2 Cycle alt 3 Temperature ¹³²Û& ²⁷⁰ƒ) ¹³⁴Û& ²⁷3°F) 135Û& ²⁷5°F) Exposure time 4 Minutes 3 Minutes 3 Minutes Drying time (wrapped) 20 Minutes 16 Minutes 16 Minutes

Source page: https://510kreport.com/device/K141616
Methodology: https://510kreport.com/methodology