510(k) · Cleared
ClearedPrimeSight UltraView System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cogentix Medical, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Apr 7, 2026 as substantially equivalent to K071127 (Vision-Sciences, Inc., 2007) after a 123-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Apr 7, 2026
- Review
- 123 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921244 (1992). 18 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 7 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 6 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 5 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 4 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 3 generations backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- 2 generations backK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- 1 generation backK071127 Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc. · 2007
- This deviceK253905 PrimeSight UltraView SystemCogentix Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −7 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −6 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −5 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −4 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −3 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| −2 | K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | Vision-Sciences, Inc. | 2006 | — |
| −1 | K071127 | Flexible Hysteroscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
| 0 (this device) | K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K071127 | Flexible Hysteroscope with Endosheath SystemSummary page 5…Number Device Class Class II Review Panel Gastroenterology/Urology K071127 Primary Predicate Device K072180 Reference Dev… | 2007 |
| † | K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath System | 2007 |
| † | K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor | 2018 |
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?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K071127.
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?
PrimeSight UltraView® Hybrid Flexible Video Cystoscope: Indications for Cystoscopy: - Endoscopic access of the lower urinary tract, including the bladder. - When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures. Indications for Hysteroscopy: For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures.…
Read the full statement (106 words)
PrimeSight UltraView® Hybrid Flexible Video Cystoscope:
Indications for Cystoscopy:
- Endoscopic access of the lower urinary tract, including the bladder.
- When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures.
Indications for Hysteroscopy:
For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures.
PrimeSight UltraView® All-in-One Video Processor Unit:
The PrimeSight UltraView® All-in-One Video Processor Unit, when used in conjunction with a Laborie flexible videoscope (i.e., UV-6000 or UV-6000i) with Slide-On® EndoSheath® Technology, is indicated for the display and management of video and images during cystoscopy and hysteroscopy procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253905 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253905: PrimeSight UltraView System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253905
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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