510(k) · Cleared
ClearedCORIS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosonics Limited · SEW Automated Endoscope Channel Cleaner
Cleared on Mar 5, 2026 as substantially equivalent to DEN240018 (Nanosonics Limited, 2025) after a 157-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Mar 5, 2026
- Review
- 157 days
- Class
- Class II
- Product code
- SEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240018 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240018 CORIS SystemNanosonics Limited · 2025
- This deviceK253267 CORIS SystemNanosonics Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240018 | CORIS System | Nanosonics Limited | 2025 | — |
| 0 (this device) | K253267 | CORIS System | Nanosonics Limited | 2026 | — |
Sources: FDA 510(k) 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 SEW? 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN240018 | CORIS SystemSummary page 5…SEW V. PREDICATE DEVICE Predicate Device Trade Name: CORIS System De Novo Classification Number: DEN240018 Company Name: Nanosonics Ltd. VI. DEVICE DESCRIPTION The CORIS System is an automated electromecha… | 2025 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All SEW devicesSEW Automated Endoscope Channel Cleaner: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SEW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SEW
Too few SEW 510(k)s in any year since 2007 to give a median.
Recalls per year · SEW
No recall names SEW since 2007.
Adverse event reports per year · SEW
No MAUDE report names SEW since 2007.
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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Nanosonics CORIS System is indicated for cleaning of the channels of compatible endoscopes.
The CORIS System is suitable for use in healthcare facilities by trained healthcare personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253267: CORIS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253267
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026