De Novo · Granted
GrantedZuno Smart Sterilization Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zuno Medical, Inc. · QJT Rigid Sterilization Container With Software
Granted on Jun 17, 2022 as a new device type through De Novo after a 486-day review.
- Decided
- Jun 17, 2022
- Review
- 486 days
- Class
- Class II
- Product code
- QJT
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QJT devicesQJT Rigid Sterilization Container With Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QJT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QJT
Too few QJT 510(k)s in any year since 2007 to give a median.
Recalls per year · QJT
No recall names QJT since 2007.
Adverse event reports per year · QJT
1in 2024
MAUDE reports naming product code QJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (121 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210004 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210004: Zuno Smart Sterilization Container.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210004
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026