# DEN210004: Zuno Smart Sterilization Container

- Pathway: De Novo (Direct)
- Applicant: Zuno Medical, Inc.
- Decided: Jun 17, 2022 after 486 days
- Product code: QJT (Rigid Sterilization Container With Software)
- Device class: 2
- Regulation: 21 CFR 880.6855
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Zuno Smart Sterilization Container is a reusable sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider with pre-vacuum, steam sterilization cycles, to maintain sterility after removal from the sterilizer until used, and to monitor and inform users of the status of the container's sterile barrier integrity. The Zuno Smart Sterilization Container has been validated to allow for the sterilization of its contents in pre-vacuum steam sterilizers with the following parameters: 132 ℃ sterilization temperature, 4-minute sterilization, 30-minute dry time. Do not use with instruments containing lumens with an inner diameter smaller than 1.2mm and an overall length longer than 500mm. Do not exceed a total container weight of 251bs.

Source page: https://510kreport.com/device/DEN210004
Methodology: https://510kreport.com/methodology