# K152241: Medtronic Transportation/Sterilization Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jan 20, 2016 after 163 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: 6 generations back to K844002 (1984). 12 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131455: Restore Modular Sterilization Tray System, Restore Medical Solutions, Inc. (2013) Summary page 5.
- K033222: Olympus Sterilization Trays, Olympus Winter & Ibe GmbH (2004) Summary page 5.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 5.
- K120947: THS Instrument Tray, Hologic, Inc. (2012) Summary page 5.

## Most influential descendants
- K163600: Kit Boxes and Kit Plates (2018), 18 descendants of its own
- K180791: Straumann BLX Surgical Cassette (2018), 11 descendants of its own
- K212281: Surgical Trays (2022), 5 descendants of its own
- K181075: PureSet Tray (2018), 5 descendants of its own
- K191475: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate (2019), 4 descendants of its own

## Indications for use
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassette (22.75 x 11.26 x 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated total weight was 28.4lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassette included the following worst case lumen dimensions. - 363 x 1.575mm - 247.5 x 4.1mm Device List: 1850060 Case - Triple Generic Outer Base (22.74 x 11.260 x 5.040 inches) 1850064 Lid - Generic Outer Lid (22.75 x 11.260 x 0.470 inches) 7022101L Tray Lid (21 x 10.13 x 0.075 inches) P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches) P1850062 Tray 2 (21 x 10.13 x 1.69 inches) P1850063 Tray 3 (21 x 10.13 x 1.38 inches) 7059532 Large Caddy (9.47 x 6.37 x 1.3 inches) 7059532L Large Lid (5.85 x 4.725 x 0.095 inches) P9213018 Small Caddy (2 x 1.5 x 1.025 inches) P9213018 Small Lid (2 x 1.29 x 0.095 inches) Sterilization Parameters: Cycle Temperature Exposure time Minimum dry time Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes Dynamic-Air-Removal (4 Pre-conditioning pulses) 270°F (132°C) 4 Minutes 30 Minutes Dynamic-Air-Removal (4 Pre-conditioning pulses) 275°F (135°C) 3 Minutes 30 Minutes

Source page: https://510kreport.com/device/K152241
Methodology: https://510kreport.com/methodology