# K172726: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 30, 2018 after 231 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 30 ancestors in all.
7 later devices descend from it; 4 cite it directly.
7 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121959: Evis Exera Iii Video System, Olympus Medical Systems Corp. (2013) Summary page 5.
- K950636: Olympus Disposable Biopsy Forceps, Olympus America, Inc. (1995) Summary page 5.

## Most influential descendants
- K183419: EVIS EXERA III Bronchovideoscope Olympus BF-XT190 (2019), 2 descendants of its own
- K201758: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 (2021), 1 descendant of its own
- K192164: Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR (2020), 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
- K250957: Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) (2025), 0 descendants of its own

## Recalls of this device
- 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-2497-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

## 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. The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope.

Source page: https://510kreport.com/device/K172726
Methodology: https://510kreport.com/methodology