Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299)
Description
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance by Ambu A/S, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223299
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. Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD ... | Ambu A/S | 2022 |
| K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3... | Ambu A/S | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope... | Hunan Vathin Medical Instrument Co.... | 2024 |
| K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.... | Ambu A/S | 2024 |
Trace the full predicate network for K223299
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.