510(k) · Cleared
ClearedAmbu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2
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 Oct 16, 2024 as substantially equivalent to K193095 (Ambu A/S, 2020) and 1 other predicate after a 203-day review. Its family tree reaches back 10 generations to 1992. 3 of the 54 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 16, 2024
- Review
- 203 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K921244 (1992). 53 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations between
- 3 generations backK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
- 2 generations backK160766 Ambu USR, Ambu MAmbu A/S · 2016
- 1 generation backK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- This deviceK240849 Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5…Ambu A/S · 2024
Show all 10 generations
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 9 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 8 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 7 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 6 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 5 generations backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- 4 generations backK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- 3 generations backK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
- 2 generations backK160766 Ambu USR, Ambu MAmbu A/S · 2016
- 1 generation backK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- This deviceK240849 Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5…Ambu A/S · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −9 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −8 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −7 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −6 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −5 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| −4 | K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | Vision-Sciences, Inc. | 2006 | — |
| −3 | K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
| −2 | K160766 | Ambu USR, Ambu M | Ambu A/S | 2016 | — |
| −1 | K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020 | — |
| 0 (this device) | K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD… | Ambu A/S | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 1 |
| 2005 | 2 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 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.
3 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 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 |
|---|---|---|---|
| * | K193095 | Ambu aScope 4 CystoSummary page 5…OPIC VIDEO IMAGING SYSTEM/COMg I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193095 Ambu® aScope™ 4 Cysto FAJ K230332 Ambu® aBox™ 2 FET Device Description Summary 21 CFR 807.92(a)(4) The Ambu® aScope™ 5 Cysto HD… | 2020 |
| * | K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2Summary page 5…egally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193095 Ambu® aScope™ 4 Cysto FAJ K230332 Ambu® aBox™ 2 FET Device Description Summary 21 CFR 807.92(a)(4) The Ambu® aScope™ 5 Cysto HD System is a combination of an endo… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 17 of the 53 ancestors have a recall of any class; 3 have a Class I recall.
- 9 other devices also cite its predicate K193095.
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. 2024, 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?
aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240849 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240849: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240849
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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