510(k) · Cleared
ClearedAmbu aScope 4 Cysto
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Apr 2, 2020 as substantially equivalent to K160766 (Ambu A/S, 2016) after a 147-day review. Its family tree reaches back 9 generations to 1992. 2 of the 57 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Apr 2, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921244 (1992). 43 ancestors in all, the oldest K843084 (1985). 13 later devices descend from it, 10 citing it directly. 2 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations between
- 3 generations backK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- 2 generations backK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
- 1 generation backK160766 Ambu USR, Ambu MAmbu A/S · 2016
- This deviceK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- Descendant · cites it directly · 1 of its ownK222162 Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU…Shanghai AnQing Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK222602 Pusen Single Use Flexible Video Cystoscope System (Single Use…Zhuhai Pusen Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK212202 WiScope Digital Cystoscope System, WiScope Single-Use Digital…OTU Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK251140 Zenflow Spring ScopeZenflow, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252598 Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 8 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 7 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 6 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 5 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 4 generations backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- 3 generations backK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- 2 generations backK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
- 1 generation backK160766 Ambu USR, Ambu MAmbu A/S · 2016
- This deviceK193095 Ambu aScope 4 CystoAmbu A/S · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd. · 2022 · cites it directly1descendant
- K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc. · 2022 · cites it directly1descendant
- K251140Zenflow Spring ScopeZenflow, Inc. · 2025 · cites it directly0descendants
- K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −8 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −7 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −6 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −5 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −4 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| −3 | K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | Vision-Sciences, Inc. | 2006 | — |
| −2 | K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
| −1 | K160766 | Ambu USR, Ambu M | Ambu A/S | 2016 | — |
| 0 (this device) | K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020 | — |
| +1 | K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video… | Zhuhai Pusen Medical Technology Co., Ltd. | 2022 | — |
| +1 | K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible… | OTU Medical, Inc. | 2022 | — |
| +1 | K251140 | Zenflow Spring Scope | Zenflow, Inc. | 2025 | — |
| +2 | K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 1 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have a Class I recall. 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 K241500 Endoscopic Video Image Processor…score 15.2 · 6 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 |
|---|---|---|---|
| * | K160766 | Ambu USR, Ambu MSummary page 4…Product Codes: FAJ 21 CFR 876.1500 Class II Legally Predicate Device: Marketed Ambu® USR, Ambu® M, (K160766), Ambu A/S devices to which the device is Reference Device: substantially VISERA Cystovideoscope CY… | 2016 |
| † | K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope… | 2014 |
What descends from it? (13)
See all 1310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | 2022 | 1 |
| K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope… | 2022 | 1 |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope… | 2022 | 1 |
| K251140 | Zenflow Spring Scope | 2025 | 0 |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01… | 2024 | 0 |
| K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse… | 2024 | 0 |
| K240227 | LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) | 2024 | 0 |
| K231118 | Cystoscope System | 2023 | 0 |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | 2023 | 0 |
| K221580 | Single-Use Flexible Cystoscope | 2022 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 14 of the 43 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K222162 (Shanghai AnQing Medical Instrument Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
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. 2020, 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?
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories.
Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment.
Ambu® aScope™ 4 Cysto is designed for use in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193095: Ambu aScope 4 Cysto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193095
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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