# K222014: EXALT Model B Single-Use Bronchoscope

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 28, 2022 after 20 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921244 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211030: EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor, Boston Scientific Corporation (2021) Summary page 4.

## Indications for use
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K222014
Methodology: https://510kreport.com/methodology