Class Class II
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (K230948)
Description
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope by Verathon Medical (Canada) Ulc, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230948
Clearance Date2023-05-03
Clearance TypeSpecial
Product CodeEOQ
Regulation Number874.4680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230948
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (K230948) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2021 |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co.... | 2025 |
Trace the full predicate network for K230948
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.