510(k) · Cleared
ClearedCytoSure Urinary Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emmy Medical · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Dec 19, 2014 as substantially equivalent to K040390 (Stryker Endoscopy, 2004) after a 130-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 130 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040390 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK040390 Stryker Urology and Gynecology Hardware SystemStryker Endoscopy · 2004
- This deviceK142194 CytoSure Urinary Access SystemEmmy Medical · 2014
- Descendant · cites it directly · 0 of its ownK181346 CystoSure Plus CatheterEmmy Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK172422 Kohli Urinary Drainage CatheterNellie Medical, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040390 | Stryker Urology and Gynecology Hardware System | Stryker Endoscopy | 2004 | — |
| 0 (this device) | K142194 | CytoSure Urinary Access System | Emmy Medical | 2014 | — |
| +1 | K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | 2018 | — |
| +1 | K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
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 |
|---|---|---|---|
| * | K040390 | Stryker Urology and Gynecology Hardware SystemSummary page 4…lation Number(s): Predicate: 21 CFR 876.1500 Accessory: 21 CFR 876.5130 Predicate Device (s): Cystoscope: K040390 Stryker Urology and Gynecology Hardware System Reference: K080560 Henke Sass Wolf of America Arthroscope Access Cath… | 2004 |
| † | K080560 | Henke Sass Wolf of America Arthroscope | 2008 |
| † | K910486 | 8 FR Single Lumen High Performance Catheter | 1991 |
| † | K063442 | All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor | 2007 |
| † | K132686 | Aquarius Low Profile Gastrostomy Feeding Tube | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2014, 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 CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.
The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures.
The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142194: CytoSure Urinary Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142194
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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