# K201758: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 21, 2021 after 206 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 32 ancestors in all.
1 later device descends from it; 1 cites 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)
- K183419: EVIS EXERA III Bronchovideoscope Olympus BF-XT190, Olympus Medical Systems Corp. (2019) Summary page 5.

## Most influential descendants
- 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
- Dec 4, 2023 · Class II · Z-0687-2024: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Dec 4, 2023 · Class II · Z-0686-2024: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Oct 12, 2023 · Class I · Z-0194-2024: 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
- Sep 25, 2023 · Class II · Z-0327-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Jul 27, 2023 · Class II · Z-2500-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Jul 20, 2022 · Class II · Z-1559-2022: The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

## 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. 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/K201758
Methodology: https://510kreport.com/methodology