# K201026: sOLVe Tube

- Pathway: 510(k) (Traditional)
- Applicant: Hytek Medical, Inc.
- Decided: Aug 10, 2021 after 477 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771219 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051522: Silbroncho Double Lumen Tube, Fuji Systems Corp. (2005) Summary page 4.

## Indications for use
The sOLVe Tube™ is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

Source page: https://510kreport.com/device/K201026
Methodology: https://510kreport.com/methodology