# K152438: ETView VivaSight-SL (TVT) system

- Pathway: 510(k) (Traditional)
- Applicant: Etview, Ltd.
- Decided: Feb 25, 2016 after 182 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: 5 generations back to K822082 (1982). 14 ancestors in all.
1 later device descends from it; 1 cites 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)
- K121028: Etview Tracheoscopic Ventilation Tube (TVT (TM)), Etview, Ltd. (2012) Summary page 5.
- K090777: Ezc Medical, LLC Intubaidflex, Ezc Medical, LLC (2009) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The VivaSight-SL (TVT) 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. VivaSight-SL (TVT) System is compatible for use with Laryngeal Mask Airway (LMA).

Source page: https://510kreport.com/device/K152438
Methodology: https://510kreport.com/methodology