# K210883: aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

- Pathway: 510(k) (Special)
- Applicant: Ambu A/S
- Decided: Jun 17, 2021 after 84 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: 10 generations back to K921244 (1992). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor, Ambu A/S (2018) Summary page 4.

## Most influential descendants
- K242416: Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (2025), 0 descendants of its own
- K241612: Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (2024), 0 descendants of its own

## Indications for use
aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. It is designed for use in adults and intended for use in a hospital environment. It is intended to provide visualization via Ambu Displaying Unit.

Source page: https://510kreport.com/device/K210883
Methodology: https://510kreport.com/methodology