510(k) · Cleared
ClearedVision-Sciences CST-2000 Flexible Cystoscope with Slide-on 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 Apr 15, 2004 as substantially equivalent to K031786 (Vision-Sciences, Inc., 2003) and 3 other predicates after a 76-day review. Its family tree reaches back 5 generations to 1992. 26 later devices descend from it.
- Decided
- Apr 15, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921244 (1992). 14 ancestors in all, the oldest K843084 (1985). 26 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 4 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 3 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 2 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 1 generation backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- This deviceK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- Descendant · cites it directly · 23 of its ownK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- Descendant · cites it directly · 20 of its ownK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
- Descendant · 2 generations on · 14 of its ownK160766 Ambu USR, Ambu MAmbu A/S · 2016
- Descendant · 3 generations on · 13 of its ownK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- Descendant · cites it directly · 5 of its ownK071127 Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc. · 2007
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006 · cites it directly23descendants
- K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007 · cites it directly20descendants
- K160766Ambu USR, Ambu MAmbu A/S · 2016 · 2 generations on14descendants
- K193095Ambu aScope 4 CystoAmbu A/S · 2020 · 3 generations on13descendants
- K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc. · 2007 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −4 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −3 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −2 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −1 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
| +2 | K160766 | Ambu USR, Ambu M | Ambu A/S | 2016 | — |
| +3 | K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020 | — |
| +1 | K071127 | Flexible Hysteroscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
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 |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 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 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath SystemSummary page 1…According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K031786 - VSI Esophagoscope with Slide-On EndoSheath® K021344 - VSI Bronchoscope with Slide-On EndoSheath® Sys… | 2003 |
| * | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath SystemSummary page 1…Cosmetic Act, the device classification is Class II. Predicate Devices: K031786 - VSI Esophagoscope with Slide-On EndoSheath® K021344 - VSI Bronchoscope with Slide-On EndoSheath® System Manufactured by: Vision… | 2002 |
| * | K914008 | Pentax Cystofiberscope, Model Fcy-15PSummary page 1…by: Vision-Sciences, Inc. 9 Strathmore Road Natick, MA 01760 K914008 - Pentax FCY-15P2 Flexible Fiberoptic Cystoscope K843084 - Olympus CYF-4 Flexible Fiberoptic Cystoscop… | 1992 |
| * | K843084 | Olympus CHP-P10 Nephroscope/CystoscopeSummary page 1…trathmore Road Natick, MA 01760 K914008 - Pentax FCY-15P2 Flexible Fiberoptic Cystoscope K843084 - Olympus CYF-4 Flexible Fiberoptic Cystoscope Product Description: The device system described in this 510(k) consists of a fl… | 1985 |
What descends from it? (26)
See all 265 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | 2006 | 23 |
| K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath System | 2007 | 20 |
| K071127 | Flexible Hysteroscope with Endosheath System | 2007 | 5 |
| K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for… | 2006 | 0 |
| K061324 | Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 | 2006 | 0 |
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 12 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K053560 (Vision-Sciences, Inc., 2006) has gone furthest, with 23 descendants of its own.
- 7 other devices also cite its predicate K031786.
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.
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?
For endoscopic access and examination of the lower urinary tract including the
bladder and, using additional accessories, to perform various diagnostic and
therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on 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/K040215
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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