510(k) · Cleared
ClearedAmbu aScope 4 RhinoLaryngo Slim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on May 22, 2019 as substantially equivalent to K181286 (Ambu A/S, 2018) after a 28-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- May 22, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931154 (1993). 10 ancestors in all, the oldest K850978 (1985). 4 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 4 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 3 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 2 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 1 generation backK181286 Ambu aScope RLS SlimAmbu A/S · 2018
- This deviceK191080 Ambu aScope 4 RhinoLaryngo SlimAmbu A/S · 2019
- Descendant · cites it directly · 0 of its ownK253184 Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope…Zhuhai Wesee Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK232435 Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK214050 ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis) · 2022
- Descendant · cites it directly · 0 of its ownK220004 Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd. · 2026 · cites it directly0descendants
- K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd. · 2024 · cites it directly0descendants
- K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis) · 2022 · cites it directly0descendants
- K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −5 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −4 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −3 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −2 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −1 | K181286 | Ambu aScope RLS Slim | Ambu A/S | 2018 | — |
| 0 (this device) | K191080 | Ambu aScope 4 RhinoLaryngo Slim | Ambu A/S | 2019 | — |
| +1 | K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A… | Zhuhai Wesee Meditech Co., Ltd. | 2026 | — |
| +1 | K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024 | — |
| +1 | K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | 2022 | — |
| +1 | K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
Planning a device in EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 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? (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 |
|---|---|---|---|
| * | K181286 | Ambu aScope RLS SlimSummary page 4…rer Trade Name number devices to which Predicate Ambu A/S Ambu® aScope™ RLS K181286 the device is C: Slim substantially equivalent Reference: Olympu… | 2018 |
| † | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | 2001 |
| † | K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular… | 2018 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K253184 (Zhuhai Wesee Meditech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181286.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
The endoscope is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor.
The endoscope is intended for use in a hospital environment. It is designed for use in adults.
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/K191080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191080: Ambu aScope 4 RhinoLaryngo Slim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191080
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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