De Novo · Granted
GrantedAurie System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathbuddy, Inc. · SHV Reusable Intermittent Urinary Catheter System
Granted on Apr 30, 2026 as a new device type through De Novo after a 328-day review.
- Decided
- Apr 30, 2026
- Review
- 328 days
- Class
- Class II
- Product code
- SHV
- 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 SHV? 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 SHV devicesSHV Reusable Intermittent Urinary Catheter System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHV
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHV
Too few SHV 510(k)s in any year since 2007 to give a median.
Recalls per year · SHV
No recall names SHV since 2007.
Adverse event reports per year · SHV
No MAUDE report names SHV 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 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Aurie Reusable No-Touch Intermittent Catheter System (or Aurie System) is indicated for the drainage of urine from the bladder for adult males requiring intermittent catheterization. Prior to use, the Aurie Catheter must be cleaned, high-level disinfected, and lubricated with the Aurie Personal Washer-Disinfector. It is for single patient reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250023 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250023: Aurie System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250023
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026