# Shenzhen Insighters Medical Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 3 (2023–2025): 3 510(k) clearances
- Product codes: CBI (2), EOQ (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ambu A/S: 2 (https://510kreport.com/company/ambu-a-s)
- Daiken Medical Co, Ltd.: 1 (https://510kreport.com/company/daiken-medical)

## Recent decisions
- 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. (May 28, 2025)
- K232529: Disposable Double Lumen Endobronchial Tube (May 13, 2024)
- K232580: Disposable Endobronchial Blocker Tube (Dec 14, 2023)

Source page: https://510kreport.com/company/shenzhen-insighters-medical-technology