# K203177: Sterisystem Dry-Base Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: O&M Halyard, Inc.
- Decided: Jan 2, 2022 after 433 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: 8 generations back to K844002 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102122: Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428, Smith & Nephew, Inc. (2010) Summary page 5.

## Indications for use
The Sterisystem Dry-Base Instrument Tray are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature 132oC (270oF) Sterilization Time 4 minutes Drying time 30 Maximum Tray Weight Up to 25lbs depending on the weight limit of the cleared sterilization wrap used. Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.

Source page: https://510kreport.com/device/K203177
Methodology: https://510kreport.com/methodology