# K211947: GlideScope BFlex 2.8 Single-Use Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Verathon Medical (Canada) Ulc
- Decided: Nov 3, 2021 after 133 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: 11 generations back to K921244 (1992). 27 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193488: GlideScope BFlex 3.8 Single-Use Bronchoscope, Verathon Medical (Canada) Ulc (2020) Summary page 5.
- K183256: GlideScope BFlex Single-Use Bronchoscope System, Verathon Medical (Canada) Ulc (2019) Summary page 5.
- K191948: GlideScope BFlex 5.8 Single-Use Bronchoscope, Verathon Medical (Canada) Ulc (2019) Summary page 5.

## Most influential descendants
- K230948: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (2023), 2 descendants of its own
- K261637: Single-use Flexible Bronchoscope (2026), 0 descendants of its own
- K250232: Vathin® Video Bronchoscope System (2025), 0 descendants of its own

## Indications for use
GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with a video monitor, in conjunction with non-powered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K211947
Methodology: https://510kreport.com/methodology