# K121028: Etview Tracheoscopic Ventilation Tube (TVT (TM))

- Pathway: 510(k) (Traditional)
- Applicant: Etview, Ltd.
- Decided: Jun 21, 2012 after 77 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K822082 (1982). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082420: Tracheoscopic Ventilation Tube (TVT), Etview (2008) Summary page 2.
- K093888: Coopdech Endobronchial Blocker Tube, Daiken Medical Co, Ltd. (2010) Summary page 2.

## Most influential descendants
- K152438: ETView VivaSight-SL (TVT) system (2016), 1 descendant of its own
- K250243: ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (2025), 0 descendants of its own
- K181880: VivaSight-SL (TVT) system (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K121028
Methodology: https://510kreport.com/methodology