510(k) · Cleared
ClearedCFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verathon Medical (Canada) Ulc · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on May 11, 2026 as substantially equivalent to K240848 (Ambu A/S, 2024) after a 171-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- May 11, 2026
- Review
- 171 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K240848 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK240848 Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5…Ambu A/S · 2024
- This deviceK253696 CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope…Verathon Medical (Canada) Ulc · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K240848 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD… | Ambu A/S | 2024 | — |
| 0 (this device) | K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse… | Verathon Medical (Canada) Ulc | 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 FAJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K240848 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Summary page 5…mbu aScope 5 Cysto HD (Standard and Reverse Deflection) and aView 2 Advance Gen. 2 Monitor 510(k) # K240848 Reference Device: Ambu aScope 4 Cysto 510(k) # K193095 Review Panel:… | 2024 |
| † | K193095 | Ambu aScope 4 Cysto | 2020 |
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 FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
The CFlex Single-use Cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via compatible Verathon monitor and can be used with endoscopic accessories.
The cystoscope is intended for use in adults requiring cystoscopy by qualified urology professionals in a clinic, hospital or ambulatory surgery center (ASC) environment.
The CystoView monitor is intended to display live imaging data from the CFlex Single-use Cystoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253696: CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253696
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026