Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013528571

FEI Number

3013528571

Entity Name

SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 13th, HTM Building, Ganli Road, Longgang District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Insighters Medical Technology Co., Ltd. (Owner Number: 10053495)

Owner / Operator Contact Address

The 13th floor of Hengtemei Building,Ganli Road No. 3, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232529

PMA Number

N/A

All Registered Proprietary Names

Laryngeal Mask Airway Model: iS-LMA-A30, iS-LMA-A40, S-LMA-A50 Model:iSLMAVA15Y 1.5#;iSLMAVA20Y 2#;iSLMAVA25Y 2.5#;iSLMAVA30Y 3#;iSLMAVA40Y 4#;iSLMAVA50Y 5# Model:iSLMAC10 1#;iSLMAC15 1.5#;iSLMAC20 2#;iSLMAC25 2.5#;iSLMAC30 3#;iSLMAC40 4#;iSLMAC50 5# Disposable Laryngeal Mask Airway Model:iSLMAVB15Y 1.5#;iSLMAVB20Y 2#;iSLMAVB25Y 2.5#;iSLMAVB30Y 3#;iSLMAVB40Y 4#;iSLMAVB50Y 5# Model:iSLMAA10 1#;iSLMAA15 1.5#;iSLMAA20 2#;iSLMAA25 2.5#;iSLMAA30 3#;iSLMAA40 4#;iSLMAA50 5# Model:iSLMAVC15Y 1.5#;iSLMAVC20Y 2#;iSLMAVC25Y 2.5#;iSLMAVC30Y 3#;iSLMAVC40Y 4#;iSLMAVC50Y 5# Single-use Video Laryngeal Mask Airway Model:iSLMAB10 1#;iSLMAB15 1.5#;iSLMAB20 2#;iSLMAB25 2.5#;iSLMAB30 3#;iSLMAB40 4#;iSLMAB50 5# Disposable Blade Video Flexible Laryngoscope,Model: iS3-C; iS3-FN2; iS3-F; iS3-C4; iS3-C5; iS3-C6; iS3-F2; iS3-F3;iS-B01 Insight Workstation, Model: iS-PF1, iS-PF2 Insight Workstation Accessory-Wireless Module, Connection Cable,Power Adapter Insight Workstation Accessory-Trolley:iS-TC1,iS-TC2 Disposable Endobronchial Blocker Tube:5Fr;7Fr;9Fr Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5/2.6 Single-use Flexible Video Bronchoscope Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2 Insighters Insight Workstation iS-PF 1 Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6/3 Stylet: insight ST1 Tracheal Tube Adapter Model: QT01 Video Laryngoscope,Model: iS3-L Video Rigid Laryngoscope, Model: iS3-R Video Laryngoscope, Model: insight iS6 Video Laryngoscope, Model: insight iS2 Single-Use Laryngoscope Blade,Model: i6-SS;i6-S;i6-M;i6-L;SS;S;M;L Video Laryngoscope Accessory-Handle (iS6-H) Video Laryngoscope Accessory-Handle (iS3) Video Laryngoscop Accessory-3.5 inch Host (iS6-M) Video Laryngoscope, Model: iS-NEO Video Laryngoscope Accessory-Power Adapter Video Laryngoscope Accessory- 3.5 inch Host (iS3) Video Laryngoscope Accessory-Handle (NEO-0/NEO-1) Single-Use Laryngoscope Blade,Model: MAC1 SS;MAC2 S;MAC3 M;MAC4 L;SS-Pro;S-Pro;M-Pro;L-Pro;MAC3;MAC4 Disposable Closed Suction Catheter Long-acting Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr Child Type: 6Fr,8Fr Standard Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr Disposable Suction Catheter,Model:iSKX06 6Fr;iSKX08 8Fr;iSKX10 10Fr;iSKX12 12Fr;iSKX14 14Fr;iSKX16 16Fr Disposable Double Lumen Endobronchial Tube (Visible Right 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) 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 (Visible 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-12-23
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-12-09
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2016-12-09
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2020-04-29
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2023-12-21
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-06-02
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2022-11-21
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2021-12-23
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-12-09
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2021-12-21
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2024-05-21

Official Correspondent

Baohong Fang

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shenzhen Insighters Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K071694	Daiken Medical Co, Ltd.	COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX	2008-03-20
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Similar Registrations

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3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013528571. Last updated year: 2026. Please use registration number 3013528571 when referencing this establishment in official correspondence.