# K211030: EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 9, 2021 after 125 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: 10 generations back to K921244 (1992). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor, Ambu A/S (2018) Summary page 4.

## Most influential descendants
- K222014: EXALT Model B Single-Use Bronchoscope (2022), 0 descendants of its own

## Indications for use
EXALT Model B Single-Use Bronchoscope: The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree. EXALT Monitor: The EXALT Monitor is intended for use with a Boston Scientific single-use endoscope for endoscopic diagnosis, treatment, and video observations.

Source page: https://510kreport.com/device/K211030
Methodology: https://510kreport.com/methodology