510(k) · Cleared
ClearedThe Visualized Endotracheal Tube System or Vett System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmonx · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Feb 13, 1998 after a 172-day review. The FDA summary names its predicate without a number. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Feb 13, 1998
- Review
- 172 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- This deviceK973191 The Visualized Endotracheal Tube System or Vett SystemPulmonx · 1998
- Descendant · cites it directly · 16 of its ownK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- Descendant · 2 generations on · 14 of its ownK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- Descendant · 3 generations on · 4 of its ownK113576 Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012
- Descendant · 4 generations on · 3 of its ownK123853 Vivasight-DL SystemEtview, Ltd. · 2013
- Descendant · 3 generations on · 3 of its ownK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193058 SonarMed AirWave Airway Monitoring System5 generations on · 2020
Most influential descendants
Showing 5 of 17 · See all- K052233Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005 · cites it directly16descendants
- K082420Tracheoscopic Ventilation Tube (TVT)Etview · 2008 · 2 generations on14descendants
- K113576Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012 · 3 generations on4descendants
- K123853Vivasight-DL SystemEtview, Ltd. · 2013 · 4 generations on3descendants
- K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973191 | The Visualized Endotracheal Tube System or Vett System | Pulmonx | 1998 | — |
| +1 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| +2 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| +3 | K113576 | Double Lumen Video Tracheosdope (DLVT) System | Etview, Ltd. | 2012 | — |
| +4 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
| +3 | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (5)
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 |
|---|---|---|---|
| * | — | Mallinckrodt Hi-Lo Tracheal Tube with Cuff Named without a submission number | |
| * | — | Olympus LF1/LF2 Tracheal Intubation Fiberscope Named without a submission number | |
| * | — | A.O. LS6A/LS7 Fiberoptic Laryngoscope Named without a submission number | |
| * | — | Welch Allyn Hi-Lux HLS-24W Illuminator Named without a submission number | |
| * | — | UroHealth Integrated Visualization System, END-101 Named without a submission number |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052233 | Tracheoscopic Ventilation Tube (TVT) System | 2005 | 16 |
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.
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K052233 (Etview, Ltd., 2005) has gone furthest, with 16 descendants of its own.
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.
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 Pulmonx Visualized Endotracheal Tube (VETT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation, for oral and nasal intubations.
The VETT System is indicated for viewing during difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.
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/K973191 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973191: The Visualized Endotracheal Tube System or Vett System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973191
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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