Data / Medical devices / China / Shenzhen Insighters Medical Technology Co., Ltd.
Shenzhen Insighters Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Insighters Medical Technology Co., Ltd. is registered with the FDA (registration 3013528571) in Shenzhen Guangdong, China. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013528571
- Address
- Floor 13th, HTM Building, Ganli Road Longgang District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Insighters Medical Technology Co., Ltd. (10053495)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 9, 2016
- Registered through
- 2026
- Brand names listed
- Child Type: 6Fr,8Fr, Disposable Blade, Disposable Closed Suction Catheter, Disposable Double Lumen Endobronchial Tube (Ordinary Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Ordinary Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Visible Left Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Visible Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Visible Right Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2025 | 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. | EOQ | Substantially Equivalent | Shenzhen Insighters Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 13, 2024 | K232529 | Disposable Double Lumen Endobronchial Tube | CBI | Substantially Equivalent | Shenzhen Insighters Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 14, 2023 | K232580 | Disposable Endobronchial Blocker Tube | CBI | Substantially Equivalent | Shenzhen Insighters Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stylet, Tracheal Tube
- All makers of Laryngoscope, Non-Rigid
- All makers of Instrument, Ent Manual Surgical
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Connector, Airway (Extension)
- All makers of Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Updated May 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.