# K221631: Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 26, 2022 after 112 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931154 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment, The Olympus Optical Co. (1998) Summary page 5.

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0339-2024: 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-2501-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- May 26, 2023 · Class II · Z-2341-2023: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 
- May 26, 2023 · Class II · Z-2340-2023: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 

## Indications for use
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management. The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

Source page: https://510kreport.com/device/K221631
Methodology: https://510kreport.com/methodology