510(k) · Cleared
ClearedDouble Lumen Video Tracheosdope (DLVT) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etview, Ltd. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on May 18, 2012 as substantially equivalent to K082420 (Etview, 2008) and 1 other predicate after a 165-day review. Its family tree reaches back 4 generations to 1982. 1 of the 14 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- May 18, 2012
- Review
- 165 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K822082 (1982). 9 ancestors in all, the oldest K771219 (1977). 4 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 3 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 2 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 1 generation backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- This deviceK113576 Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK123853 Vivasight-DL SystemEtview, Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK181886 VivaSight-DL SystemEtview, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK203749 Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S · 2021 · Recalled
- Descendant · 4 generations on · 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, Uncuffed4 generations back · 1982
Most influential descendants
Showing 4 of 4 · See all- K123853Vivasight-DL SystemEtview, Ltd. · 2013 · cites it directly3descendants
- K181886VivaSight-DL SystemEtview, Ltd. · 2018 · 2 generations on2descendants
- K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S · 2021 · 3 generations on1descendant
- K232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −3 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −2 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −1 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| 0 (this device) | K113576 | Double Lumen Video Tracheosdope (DLVT) System | Etview, Ltd. | 2012 | — |
| +1 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
| +2 | K181886 | VivaSight-DL System | Etview, Ltd. | 2018 | — |
| +3 | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | 2021 | 2 |
| +4 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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.
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 12.1 · 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? (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 |
|---|---|---|---|
| * | K082420 | Tracheoscopic Ventilation Tube (TVT)Summary page 2…ed: Device Name 510k No Date of Clearance ETVicw Tracheoscopic Ventilation K082420 October 8, 2008 Tube (TVT""I) _______… | 2008 |
| * | K092886 | Well Lead Endobronchial TubesSummary page 2…er 8, 2008 Tube (TVT""I) _______ Well LEAD Endobronchial Tubes K092886 March 11, 2010 Performance Standards Double Lumen Video Troche .oscope (DL VT7 ) was tested and… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123853 | Vivasight-DL System | 2013 | 3 |
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.
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 4 generations back · ◆ on the line of descent in FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K123853 (Etview, Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K082420.
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. 2012, 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?
The ETView Double Lumen Video Tracheoscope (DL VTM) is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia.
The DL VTTM System is indicated for verifying tube placement and repositioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113576: Double Lumen Video Tracheosdope (DLVT) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113576
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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