510(k) · Cleared
ClearedModified Endosheath System for Vsi Flexible Cystoscope
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 Mar 16, 2006 as substantially equivalent to K040215 (Vision-Sciences, Inc., 2004) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 1992. 23 later devices descend from it.
- Decided
- Mar 16, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921244 (1992). 15 ancestors in all, the oldest K843084 (1985). 23 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 1 generation backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- This deviceK053560 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
- Descendant · 2 generations on · 3 of its ownK181909 Luminelle DTx Hysteroscopy SystemUvision360, Inc. · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- 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
- K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −1 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | 2018 | — |
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 |
|---|---|---|
| 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? (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…According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class 11. Predicate Devices: K040215 - VSI CST-Dx Slide-On Cystoscope Sheath for use with VSI Flexible Cystoscope… | 2004 |
| * | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath SystemSummary page 1…1. Predicate Devices: K040215 - VSI CST-Dx Slide-On Cystoscope Sheath for use with VSI Flexible Cystoscope K031786 - VSJ TNE-BxD Slide-On EndoSheath® for use with VSI Flexible Trans-Nasal Esophagoscope… | 2003 |
What descends from it? (23)
See all 232 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 14 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K072180 (Vision-Sciences, Inc., 2007) has gone furthest, with 20 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.
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/K053560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053560: Modified Endosheath System for Vsi Flexible Cystoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053560
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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