510(k) · Cleared
ClearedAmbu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Sep 1, 2016 as substantially equivalent to K130845 (Ambu A/S, 2013) after a 77-day review. Its family tree reaches back 8 generations to 1992. 1 of the 65 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it.
- Decided
- Sep 1, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921244 (1992). 24 ancestors in all, the oldest K850978 (1985). 40 later devices descend from it, 1 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 7 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 6 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 5 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 4 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 3 generations backK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
- 2 generations backK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009
- 1 generation backK130845 Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013
- This deviceK161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu…Ambu A/S · 2016
- Descendant · cites it directly · 39 of its ownK173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2…Ambu A/S · 2018
- Descendant · 2 generations on · 10 of its ownK220606 Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2…Ambu A/S · 2022
- Descendant · 2 generations on · 8 of its ownK191828 Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd. · 2020
- Descendant · 3 generations on · 6 of its ownK223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD…Ambu A/S · 2023 · Recalled
- Descendant · 3 generations on · 4 of its ownK230428 Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2…Ambu A/S · 2023
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…2 generations back · 2003
Most influential descendants
Showing 5 of 40 · See all- K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S · 2018 · cites it directly39descendants
- K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S · 2022 · 2 generations on10descendants
- K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd. · 2020 · 2 generations on8descendants
- K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S · 2023 · 3 generations on6descendants
- K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −7 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −6 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −5 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −4 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −3 | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and… | Vision-Sciences, Inc. | 2007 | — |
| −2 | K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System… | Vision-Sciences, Inc. | 2009 | — |
| −1 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
| 0 (this device) | K161656 | Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large… | Ambu A/S | 2016 | — |
| +1 | K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope… | Ambu A/S | 2018 | — |
| +2 | K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | Ambu A/S | 2022 | — |
| +2 | K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2020 | — |
| +3 | K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®… | Ambu A/S | 2023 | 1 |
| +3 | K230428 | Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 | Ambu A/S | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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.
1 device in this family has 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 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 |
|---|---|---|---|
| * | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewSummary page 4…Legally Marketed Manufacturer Trade Name 510k number devices to which A+B: Ambu A/S Ambu® aScope 3™ K130845 the device is 5.0/2.2, Ambu® substantially aScope™ 3 Slim 3.8… | 2013 |
| † | K121959 | Evis Exera Iii Video System | 2013 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular… | 2018 | 39 |
Has anything in its family been recalled? (1 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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173727 (Ambu A/S, 2018) has gone furthest, with 39 descendants of its own.
- 3 other devices also cite its predicate K130845.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree. The aScope 3 system is for use in a hospital environment. The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes: Minimum ETT inner diameter…
Read the full statement (164 words)
The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.
The aScope 3 system is for use in a hospital environment.
The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:
Minimum ETT inner diameter Minimum DLT size
aScope 3 Slim 3.8/1.2 5.0 mm 37Fr
aScope 3 Regular 5.0/2.2 6.0 mm 41 Fr
aScope 3 Large 5.8/2.8 7.0 mm -
Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.
Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.
Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.
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/K161656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161656: Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161656
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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