510(k) · Cleared
Recalled · Class II · 2024Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on May 3, 2021 as substantially equivalent to K181886 (Etview, Ltd., 2018) after a 131-day review. Its family tree reaches back 7 generations to 1982. 1 of the 14 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 3, 2021
- Review
- 131 days
- Class
- Class II
- Product code
- CBI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K822082 (1982). 12 ancestors in all, the oldest K771219 (1977). 1 later device descends from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 6 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 5 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 4 generations backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- 3 generations backK113576 Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012
- 2 generations backK123853 Vivasight-DL SystemEtview, Ltd. · 2013
- 1 generation backK181886 VivaSight-DL SystemEtview, Ltd. · 2018
- This deviceK203749 Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S · 2021
- Descendant · cites it directly · 0 of its ownK232529 Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd. · 2024
Class I recalls in this family
- K822082 Sheridan/HVT,CF, Uncuffed7 generations back · 1982
Most influential descendants
Showing 1 of 1 · See all- K232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −6 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −5 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −4 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| −3 | K113576 | Double Lumen Video Tracheosdope (DLVT) System | Etview, Ltd. | 2012 | — |
| −2 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
| −1 | K181886 | VivaSight-DL System | Etview, Ltd. | 2018 | — |
| 0 (this device) | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | 2021 | — |
| +1 | K232529 | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 CBI device
- #1 K253096 Chartis Precision Catheterscore 12.0 · 5 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 |
|---|---|---|---|
| * | K181886 | VivaSight-DL SystemSummary page 4…Class II Predicate device Substantial equivalence to the following legally marketed device is claimed: K181886 VivaSight-DL TM, ETView Ltd.… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232529 | Disposable Double Lumen Endobronchial Tube | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2024 | Class II | Z-0261-2025 | Under Investigation by firm | Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury. |
| Jun 3, 2022 | Class II | Z-1420-2022 | Under Investigation by firm | Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient. |
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.
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 7 generations back · ◆ on the line of descent in FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 39 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232529 (Shenzhen Insighters Medical Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBI devicesCBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CBI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBI
134in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBI
83in 2025
MAUDE reports naming product code CBI, 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 | 0 | — | 0 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 1 | — | 0 | 26 |
| 2010 | 2 | — | 0 | 25 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 3 | 134 | 0 | 23 |
| 2013 | 1 | — | 0 | 26 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 2 | — | 0 | 66 |
| 2019 | 0 | — | 1 | 94 |
| 2020 | 1 | — | 0 | 87 |
| 2021 | 2 | — | 0 | 159 |
| 2022 | 1 | — | 0 | 127 |
| 2023 | 1 | — | 0 | 95 |
| 2024 | 1 | — | 1 | 75 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Intubation with Ambu VivaSight 2 DLT is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203749: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203749
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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