# K121959: Evis Exera Iii Video System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 10, 2013 after 189 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 10 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931154 (1993). 28 ancestors in all.
14 later devices descend from it; 4 cite it directly.
7 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 2.
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 2.
- K062049: Evis Exera II 180 System, Olympus Medical Systems Corporation (2006) Summary page 2.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 2.

## Most influential descendants
- K172726: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D (2018), 7 descendants of its own
- K143727: PENTAX Medical EKP-i5010 Video Processor with EB Family (2015), 3 descendants of its own
- K183419: EVIS EXERA III Bronchovideoscope Olympus BF-XT190 (2019), 2 descendants of its own
- K173679: PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (2018), 2 descendants of its own
- K232860: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (2024), 1 descendant of its own

## Recalls of this device
- Sep 11, 2025 · Class I · Z-0049-2026: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Sep 11, 2025 · Class I · Z-0053-2026: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Sep 11, 2025 · Class I · Z-0060-2026: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Sep 11, 2025 · Class I · Z-0063-2026: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Sep 11, 2025 · Class I · Z-0050-2026: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Oct 12, 2023 · Class I · Z-0192-2024: 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-2496-2023: 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.
- Jun 8, 2023 · Class I · Z-2015-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

## Indications for use
-Endoscopes (OLYMPUS BF-O190, OLYMPUS BF-H190, OLYMPUS BF-1TH19O EVIS EXERA III BRONCHOVIDEOSCOPE) This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endoherapy 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. -OLYMPUS CV-190 EVIS EXERA II VIDEO SYSTEM CENTER This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. - OLYMPUS CLV-190 EVIS EXERA I XENON LIGHT SOURCE This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Source page: https://510kreport.com/device/K121959
Methodology: https://510kreport.com/methodology