# K212656: Flexible Intubation Video Endoscope – Sterile (FIVE-S)

- Pathway: 510(k) (Special)
- Applicant: Karl Storz Endoscopy America
- Decided: Dec 29, 2021 after 128 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: 1 generation back to K071530 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071530: Karl Storz Video Flexible Video Ent Endoscope System, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 4.

## Most influential descendants
- K251731: KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (2025), 0 descendants of its own

## Recalls of this device
- Jul 7, 2023 · Class II · Z-2589-2023: Flexible intubation endoscopes sterility assurance can not be confirmed.
- Apr 1, 2022 · Class II · Z-1055-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
The Flexible Intubation Video Endoscope — Sterile (FIVE-S) are intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. 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/K212656
Methodology: https://510kreport.com/methodology