# K250029: ONE TRAY® Sealed Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Sterilization Technologies
- Decided: May 1, 2025 after 115 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 K871202 (1987). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214041: Aesculap AICON Container, Aesculap, Inc. (2022) Summary page 6.

## Indications for use
The ONE TRAY Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of 1he enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below: Prevac Steam 270°F, 4 min exposure 15 minute dry time ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm. DO NOT STACK ONE TRAY CONTAINERS DURING STERILIZATION. Examples of validated materials that can be processed within the ONE TRAY - Metals: S1ainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic. The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Catalog# Length (in) Width (in) Height (in) M2104DT 20.142 11.616 4.573 M2106DT 20.142 11.616 6.573 M2108DT 20.142 11.616 8.573 M2404DT 23.142 11.616 4.573 M2406DT 23.142 11.616 6.573 M2408DT 23.142 11.616 8.573

Source page: https://510kreport.com/device/K250029
Methodology: https://510kreport.com/methodology