510(k) · Cleared
ClearedEtview Tracheoscopic Ventilation Tube (TVT (TM))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etview, Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jun 21, 2012 as substantially equivalent to K082420 (Etview, 2008) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1982. 1 of the 16 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jun 21, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K822082 (1982). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 16 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 deviceK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK152438 ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK250243 ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)…Flexicare Medical Limited. · 2025
- Descendant · cites it directly · 0 of its ownK181880 VivaSight-SL (TVT) systemEtview, Ltd. · 2018
Class I recalls in this family
- K822082 Sheridan/HVT,CF, Uncuffed4 generations back · 1982
Most influential descendants
Showing 3 of 3 · See all- K152438ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016 · cites it directly1descendant
- K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…Flexicare Medical Limited. · 2025 · 2 generations on0descendants
- K181880VivaSight-SL (TVT) systemEtview, Ltd. · 2018 · cites it directly0descendants
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) | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
| +1 | K152438 | ETView VivaSight-SL (TVT) system | Etview, Ltd. | 2016 | — |
| +2 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)… | Flexicare Medical Limited. | 2025 | — |
| +1 | K181880 | VivaSight-SL (TVT) system | Etview, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 12.5 · 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? (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…ent's trachea. Predicate Device: substantially equivalent to the following predicate devices: ETView Tracheoscopic Ventilation Tube (TVI'r K082420 October 8, 2008 Coopdech Endobronchi… | 2008 |
| * | K093888 | Coopdech Endobronchial Blocker TubeSummary page 2…October 8, 2008 Coopdech Endobronchial Blocker tube K093888 Mach16, Performance Standards ETView Tracheoscopic Ventilation Tube (TVTrM) was tested and,… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152438 (Etview, Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K082420.
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. 2012, 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 ETView Tracheoscopic Ventilation Tube (TV7YTM) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT %) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The TVTj System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121028: Etview Tracheoscopic Ventilation Tube (TVT (TM)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121028
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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