# K183419: EVIS EXERA III Bronchovideoscope Olympus BF-XT190

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 5, 2019 after 269 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 31 ancestors in all.
2 later devices descend from it; 2 cite it directly.
7 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172726: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D, Olympus Medical Systems Corp. (2018) Summary page 4.

## Most influential descendants
- K201758: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 (2021), 1 descendant of its own
- K250862: Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190); Evis Exera Iii Bronchovideoscope (Olympus BF-XT190); Bronchovideoscope (Olympus BF-H1100); Bronchovideoscope (Olympus BF-1TH1100) (2025), 0 descendants of its own

## Recalls of this device
- Oct 12, 2023 · Class I · Z-0193-2024: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the dist
- Jul 27, 2023 · Class II · Z-2498-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Jun 8, 2023 · Class I · Z-2017-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

## Indications for use
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K183419
Methodology: https://510kreport.com/methodology