510(k) · Cleared
ClearedAmbu® aScope™ Gastro; Ambu® aScope™ Gastro Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Sep 16, 2026 as substantially equivalent to K210162 (Fujifilm Corporation, 2021) and 3 other predicates after a 140-day review. Its family tree reaches back 10 generations to 1993. 3 of the 39 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 16, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K931154 (1993). 38 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK212382 Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S · 2022
- 1 generation backK232919 Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S · 2024
- This deviceK261400 Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 6 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 5 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 4 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK212382 Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S · 2022
- 1 generation backK232919 Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S · 2024
- This deviceK261400 Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
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 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −6 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −5 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −2 | K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2 | Ambu A/S | 2022 | — |
| −1 | K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | Ambu A/S | 2024 | — |
| 0 (this device) | K261400 | Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large | Ambu A/S | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 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 |
|---|---|---|---|
| * | K210162 | Endoscope Model EI-740D/SSummary page 5….1500 Product Code(s) FDS, FAM I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210162 Endoscope Model EI-740D/S FDS K212382 Ambu® aScope™ Gastro FDS K232919 Ambu® aScope™ Gastro Large FDS K230332 Ambu® aScope™ Colon… | 2021 |
| * | K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2Summary page 5…ly Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210162 Endoscope Model EI-740D/S FDS K212382 Ambu® aScope™ Gastro FDS K232919 Ambu® aScope™ Gastro Large FDS K230332 Ambu® aScope™ Colon FDF Device Description Summary 21 CFR… | 2022 |
| * | K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Summary page 5…CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210162 Endoscope Model EI-740D/S FDS K212382 Ambu® aScope™ Gastro FDS K232919 Ambu® aScope™ Gastro Large FDS K230332 Ambu® aScope™ Colon FDF Device Description Summary 21 CFR 807.92(a)(4) The Ambu® aScope™… | 2024 |
| * | K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2Summary page 5…Trade Name (Primary Predicate is listed first) Product Code K210162 Endoscope Model EI-740D/S FDS K212382 Ambu® aScope™ Gastro FDS K232919 Ambu® aScope™ Gastro Large FDS K230332 Ambu® aScope™ Colon FDF Device Description Summary 21 CFR 807.92(a)(4) The Ambu® aScope™ Gastro and the Ambu® aScope™ Gastro Lar… | 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 · ◆ on the line of descent in 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 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 19 of the 38 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K210162.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
The device is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
The endoscope is also intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy, specifically the rectum and the sigmoid colon.
The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
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/K261400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261400
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026