510(k) · Cleared
ClearedAmbu Ascope and Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Apr 16, 2010 as substantially equivalent to K023984 (The Olympus Optical Co., 2003) and 3 other predicates after a 189-day review. Its family tree reaches back 5 generations to 1982. 2 of the 12 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 16, 2010
- Review
- 189 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K822082 (1982). 11 ancestors in all. No later device cites it as a predicate yet. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 4 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 3 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 2 generations backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- 1 generation backK090777 Ezc Medical, LLC IntubaidflexEzc Medical, LLC · 2009
- This deviceK093186 Ambu Ascope and MonitorAmbu A/S · 2010
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −4 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −3 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −2 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| −1 | K090777 | Ezc Medical, LLC Intubaidflex | Ezc Medical, LLC | 2009 | — |
| 0 (this device) | K093186 | Ambu Ascope and Monitor | Ambu A/S | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 1 |
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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 3 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 |
|---|---|---|---|
| * | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesSummary page 3…not have manoeuvrable tip as the Ambu aScope. Ambu aScone system is similar to Olympus Bronchoscop~e. BF- 160 (K023984) and Olvmpus LF-1 Tracheal intubation fiberscone (K850978) in that it consist of:… | 2003 |
| * | K850978 | Olympus LF-1 Intubation ScopeSummary page 3…system is similar to Olympus Bronchoscop~e. BF- 160 (K023984) and Olvmpus LF-1 Tracheal intubation fiberscone (K850978) in that it consist of: *A handle with a control button giving the operator the… | 1985 |
| * | K052233 | Tracheoscopic Ventilation Tube (TVT) SystemSummary page 3…monitor Ambu aScope is similar to ETView. Tracheoscopic Ventilation Tube (TVT) System (K052233) in the following areas: *It uses LED as light source located at the tip of the,… | 2005 |
| * | K090777 | Ezc Medical, LLC IntubaidflexSummary page 3…on - Amnbu® aScope T M and Amnbus aScopeT M Monitor Summary of the Ambu aScooe is similar to EZC Medical LCC. Intubaid Flex technological (K090777' in the following areas: characteristics in *They possess a similar Indication for Use. comparison to the… | 2009 |
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 3 generations back · ◆ on the line of descent in FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- 8 other devices also cite its predicate K023984.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Ambu aScope is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non difficult and difficult intubation procedures. The Ambu aScope achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu aScope is in the human anatomy. The flexible tip of the Ambu aScope allows the user to guide the ETT in the desired direction.
The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT' size 6 or larger.
Topical anesthetics can be administered via a channel with a luer connector
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093186: Ambu Ascope and Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093186
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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