# K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Sep 9, 1996 after 35 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931154 (1993). 1 ancestor in all.
573 later devices descend from it; 4 cite it directly.
14 of 575 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 1.

## Most influential descendants
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment (1998), 431 descendants of its own
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series (2003), 350 descendants of its own
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA (2002), 268 descendants of its own
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment (2001), 176 descendants of its own
- K021073: Visera Rhinlaryngovideoscope Olympus Enf Type V (2002), 160 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0337-2024: 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
- 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-2503-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Aug 8, 2018 · Class II · Z-3298-2018: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- Aug 8, 2018 · Class II · Z-3289-2018: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- Aug 8, 2018 · Class II · Z-3286-2018: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

## Indications for use
The BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K963033
Methodology: https://510kreport.com/methodology