# K200968: ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

- Pathway: 510(k) (Traditional)
- Applicant: Insung Medical Co., Ltd.
- Decided: Dec 28, 2020 after 262 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: 5 generations back to K771219 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180253: Sheridan Endobronchial Tubes, Teleflex Medical (2018) Summary page 5.

## Indications for use
This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Source page: https://510kreport.com/device/K200968
Methodology: https://510kreport.com/methodology