Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016548968

FEI Number

3016548968

Entity Name

QUADRANT TECHNOLOGIES, LLC

City/State/Country

Grayslake, IL, US

Establishment Address

888 East Belvidere Road, Suite 212, Grayslake, IL 60030, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Quadrant Technologies, LLC (Owner Number: 10062616)

Owner / Operator Contact Address

888 East Belvidere Road, Suite 212, Grayslake, IL 60030, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aero Jet Ventilation Catheter Tenax Laser Resistant Endotracheal Tube Infinity Balloon Dilation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2025-11-15
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2020-02-20
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2020-11-27
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-11-27
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-12-02

Official Correspondent

Paul Imaoka

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Quadrant Technologies, LLC

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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

Similar Registrations

Registration Number	Establishment Name	Location
3021187119	N8 MEDICAL LLC	Dublin, OH, US
3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
1420054	LSL HEALTHCARE	Niles, IL, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016548968. Last updated year: 2026. Please use registration number 3016548968 when referencing this establishment in official correspondence.