# K190840: Medtronic Transportation / Sterilization Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 15, 2019 after 197 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: 7 generations back to K844002 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152241: Medtronic Transportation/Sterilization Cassettes, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.

## 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads. Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassettes (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 28.6lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassettes included the following worst case lumen dimensions: • 363 x 1.575mm • 247.5 x 4.1mm Device list: • P l 850078 Generic Triple Outer Base (22.74x1l.26x5.04 inches) • P1850079 Generic Outer Lid (22.75xl l.26x.470 inches) • 7022101L Tray Lid (21.00x10.13x.075 inches) • P1850010 Tray 1 (20.7Ix9.82x4.4 inches) • P1850011 Tray 2 (18.8Ix9.50x2.8 inches) • P1850012 Tray 3 (18.30x9.20x.840 inches) • P1850013 Large Caddy (9.4x5.Jxl.49 inches) • P1850014 Large Lid (9.40x5.045x.095 inches) • P1850015 Small Caddy (2.00x l .50x1.025 inches) • P1850016 Small Lid (2.0xl.245x.095 inches) Sterilization Parameters Cycle Temperature Exposure time Minimum dry time Dynamic-air-removal 270° F (132° C) 4 Minutes 30 Minutes Dynamic-air-removal 275° F (135° C) 3 Minutes 30 Minutes

Source page: https://510kreport.com/device/K190840
Methodology: https://510kreport.com/methodology