# K201300: Airway Mobilescope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 26, 2021 after 256 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: 5 generations back to K931154 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082720: Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005, Olympus Medical Systems Corporation (2008) Summary page 5.

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0340-2024: 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-2499-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

## Indications for use
This instrument has been designed to be used with a Suction Pump and other ancillary equipment for airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. This instrument has been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.

Source page: https://510kreport.com/device/K201300
Methodology: https://510kreport.com/methodology