# K162600: Jewel Precision Reusable Rigid Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Jewel Precision Sheet Metal & Machine, Inc.
- Decided: Dec 9, 2016 after 81 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844652 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142529: Genesis Reusable Rigid Container System, Carefusion 2200, Inc. (2015) Summary page 4.

## Recalls of this device
- May 22, 2025 · Class II · Z-2026-2025: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

## Indications for use
The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days. Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270 °F (132 °C) for 4 minutes with a drying time of 30 minutes. Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container. Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.

Source page: https://510kreport.com/device/K162600
Methodology: https://510kreport.com/methodology