# K181880: VivaSight-SL (TVT) system

- Pathway: 510(k) (Special)
- Applicant: Etview, Ltd.
- Decided: Nov 29, 2018 after 139 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). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 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.

## Indications for use
The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVTTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral 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.

Source page: https://510kreport.com/device/K181880
Methodology: https://510kreport.com/methodology