510(k) · Cleared
ClearedVision-Sciences CST-5000 Video Cystoscope with Endosheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Dec 18, 2007 as substantially equivalent to K040215 (Vision-Sciences, Inc., 2004) and 1 other predicate after a 134-day review. Its family tree reaches back 7 generations to 1992. 20 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 134 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921244 (1992). 16 ancestors in all, the oldest K843084 (1985). 20 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 2 generations backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- 1 generation backK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- This deviceK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
- Descendant · cites it directly · 14 of its ownK160766 Ambu USR, Ambu MAmbu A/S · 2016
- Descendant · 2 generations on · 13 of its ownK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- Descendant · cites it directly · 3 of its ownK181909 Luminelle DTx Hysteroscopy SystemUvision360, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK190827 Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile…Uvision360, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK222162 Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU…Shanghai AnQing Medical Instrument Co., Ltd. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K160766Ambu USR, Ambu MAmbu A/S · 2016 · cites it directly14descendants
- K193095Ambu aScope 4 CystoAmbu A/S · 2020 · 2 generations on13descendants
- K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. · 2018 · cites it directly3descendants
- K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc. · 2019 · 2 generations on2descendants
- K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −2 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| −1 | K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | Vision-Sciences, Inc. | 2006 | — |
| 0 (this device) | K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
| +1 | K160766 | Ambu USR, Ambu M | Ambu A/S | 2016 | — |
| +2 | K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020 | — |
| +1 | K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | 2018 | — |
| +2 | K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable… | Uvision360, Inc. | 2019 | — |
| +3 | K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemSummary page 1…FAJ FDA Regulations: 21 CFR 876.1500 Device Classification: Class 1I Premarket Notification: K0402 15 / K053560 Device Description The VSl flexible endoscope is a flexible endoscope with connections to a video processor and displa… | 2004 |
| * | K053560 | Modified Endosheath System for Vsi Flexible CystoscopeSummary page 1…FAJ FDA Regulations: 21 CFR 876.1500 Device Classification: Class 1I Premarket Notification: K0402 15 / K053560 Device Description The VSl flexible endoscope is a flexible endoscope with connections to a video processor and display monitor.… | 2006 |
What descends from it? (20)
See all 203 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?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K160766 (Ambu A/S, 2016) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K040215.
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. 2007, 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 flexible video cystoscope with EndoSheath® System is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The digital video processor is intended for use with the VSI flexible video scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072180
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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