Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649914

FEI Number

3001665800

Entity Name

QUEST MEDICAL, INC.

City/State/Country

ALLEN, TX, US

Establishment Address

1 Allentown Pkwy, ALLEN, TX 75002, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ATRION CORP. (Owner Number: 9914015)

Owner / Operator Contact Address

ONE ALLENTOWN PKWY., --, Allen, TX 75002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202672

PMA Number

N/A

All Registered Proprietary Names

MPS Myocardial Protection System RLV VALVES VRV Q2 Low Pressure Power Injection Extension Set Q2 IV Extension Set Lacrimal Intubation Set Model LIS27T STENTube Lacrimal Intubation Set Model LIS052 Q-Flex, Q2 Robersite (Registered) Needlefree Injection Site Valve MPS 3 Myocardial Protection System Q2 Blood Administration Sets RETRACT-O-TAPE(R) VASCULAR LOOPS Crawford Hook; Dandy Nerve Hook Lacrimal Intubation Set, Crawford Type MPS Backup System (MPBUS) Q2® Multiport IV Administration Sets and Extension Sets Checkmate® IV Administration Sets and Extension Sets Exoflex IV Extension Sets VCC Multiport Checkmate Q2® Multiport IV Administration Sets and Extension Sets Velano Vascular Q2® Extension Set Retroguard Arterial Safety Valve VRV RLV VALVES Q2 Stopcock Qlinch Securement Band MPS2 Myocardial Protection System Lyka PORT Needle Free Access Device Q2 T-extension set LacriCATH Lacrimal Duct Catheters, Models LDC213T, LDC315T, LDC508T AORTIC PUNCH CleanCut; PerfectCut Precision Delivery Infusion Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2007-11-19
DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4430	2000-06-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-03-24
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2012-11-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-19
DWC	Controller, Temperature, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4250	2020-06-25
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2020-06-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-06-21
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-05-14
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-06-12
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2003-05-14
KRL	Detector, Bubble, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4205	2009-06-30
DXS	Gauge, Pressure, Coronary, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4310	2009-06-30
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2009-06-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2009-06-30
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2009-06-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-10-17
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2017-10-17
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2007-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-10-17
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2017-10-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-06-29
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	Cardiovascular	Class 2	870.4400	2009-05-19
DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4430	2000-06-12
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-01-25
PUK	Administration Set Securement Device	General Hospital	Class 1	880.5210	2020-04-06
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2018-11-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-05
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2007-11-19
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2012-11-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2003-05-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATRION CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000324175	Halkey-Roberts Corporation	Saint Petersburg, FL, US
1043729	ATRION MEDICAL PRODUCTS, INC.	ARAB, AL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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1319639	Sterigenics U.S., LLC	Queensbury, NY, US
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649914. Last updated year: 2026. Please use registration number 1649914 when referencing this establishment in official correspondence.