510(k) · Cleared
ClearedAmbu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
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 16, 2026 as substantially equivalent to K233671 (Ambu A/S, 2024) and 1 other predicate after a 229-day review. Its family tree reaches back 13 generations to 1992. 2 of the 45 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 16, 2026
- Review
- 229 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K921244 (1992). 44 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet. 2 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 9 generations between
- 3 generations backK220606 Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2…Ambu A/S · 2022
- 2 generations backK230428 Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2…Ambu A/S · 2023
- 1 generation backK232582 Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2023 · Recalled
- This deviceK260309 Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2…Ambu A/S · 2026
Show all 13 generations
- Root · 13 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 12 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 11 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 10 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 9 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 8 generations backK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
- 7 generations backK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009
- 6 generations backK130845 Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013
- 5 generations backK161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu…Ambu A/S · 2016
- 4 generations backK173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2…Ambu A/S · 2018
- 3 generations backK220606 Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2…Ambu A/S · 2022
- 2 generations backK230428 Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2…Ambu A/S · 2023
- 1 generation backK232582 Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2023 · Recalled
- This deviceK260309 Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2…Ambu 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 |
|---|---|---|---|---|---|
| −13 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −12 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −11 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −10 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −9 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −8 | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and… | Vision-Sciences, Inc. | 2007 | — |
| −7 | K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System… | Vision-Sciences, Inc. | 2009 | — |
| −6 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
| −5 | 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 | — |
| −4 | 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 | — |
| −3 | 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 | K230428 | Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 | Ambu A/S | 2023 | — |
| −1 | K232582 | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | 2023 | 1 |
| 0 (this device) | K260309 | Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu®… | Ambu A/S | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 1 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
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 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? (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 |
|---|---|---|---|
| * | K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceSummary page 5…r 874.4680 Product Code(s) EOQ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233671 Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aScope™ 5 EOQ Broncho 2.7/1.2 K232582 Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set EOQ Devi… | 2024 |
| * | K232582 | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetSummary page 5…7.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233671 Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aScope™ 5 EOQ Broncho 2.7/1.2 K232582 Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set EOQ Device Description Summary 21 CFR 807.92(a)(4) Ambu® aScope™ 5 Broncho is a ster… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 4 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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 14 of the 44 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K233671.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Ambu® aScope ™ 5 Broncho: aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. Ambu® aScope TM 5 Broncho Sampler Set: aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial…
Read the full statement (106 words)
Ambu® aScope ™ 5 Broncho:
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope TM 5 Broncho Sampler Set:
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
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/K260309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260309: Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260309
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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