# K251731: KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

- Pathway: 510(k) (Special)
- Applicant: Karl Storz SE & CO. KG
- Decided: Dec 5, 2025 after 182 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071530 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212656: Flexible Intubation Video Endoscope – Sterile (FIVE-S), Karl Storz Endoscopy America (2021) Summary page 5.

## Indications for use
The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor. E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

Source page: https://510kreport.com/device/K251731
Methodology: https://510kreport.com/methodology