# K242793: Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Insighters Medical Technology Co., Ltd.
- Decided: May 28, 2025 after 254 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.
No later device cites it as a predicate yet.
1 of 27 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 6.

## Indications for use
The Insighters™ Single-use Bronchoscope system provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area. It is indicated for diseases of the trachea and bronchi other than contraindications. The Insighters™ Single-use Bronchoscope system is generally in-hospital use. The Insighters™ Single-use Bronchoscope system is for use by trained clinicians/physicians only.

Source page: https://510kreport.com/device/K242793
Methodology: https://510kreport.com/methodology