Data / Medical devices / United States / Quest Medical, Inc.

Quest Medical, Inc.: FDA-registered device maker in Allen, TX, United States, 23 510(k) clearances

Name: Quest Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Quest Medical, Inc. is registered with the FDA (registration 1649914) in Allen, TX, United States. It lists 20 device types. The FDA files 23 510(k) clearances under its listings, the newest dated December 18, 2024. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1649914
FEI number: 3001665800
Address: 1 Allentown Pkwy, Allen, TX, United States, 75002
Owner or operator: ATRION CORP. (9914015)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: June 12, 2000
Registered through: 2026
Brand names listed: AORTIC PUNCH, Checkmate, CleanCut; PerfectCut, Crawford Hook; Dandy Nerve Hook, EXTENSION SET QUEST CODE #3000, FLOW CONTROL VALVE, CAT. NO. ACV-38, INFUSION, LACRICATH and more

Devices it lists

Device	Product code	Class	Role	Source
Administration Set Securement Device	PUK	1	Manufacturer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Manufacturer	accessdata.fda.gov
Controller, Temperature, Cardiopulmonary Bypass	DWC	2	Manufacturer	accessdata.fda.gov
Cpb Check Valve, Retrograde Flow, In-Line	MJJ	2	Manufacturer	accessdata.fda.gov
Detector, Bubble, Cardiopulmonary Bypass	KRL	2	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Manufacturer	accessdata.fda.gov
Gauge, Pressure, Coronary, Cardiopulmonary Bypass	DXS	2	Manufacturer	accessdata.fda.gov
Heat-Exchanger, Cardiopulmonary Bypass	DTR	2	Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Lacrimal Stents And Intubation Sets	OKS	U	Manufacturer	accessdata.fda.gov
Probe, Lachrymal	HNL	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Snare, Surgical	GAE	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Manufacturer	accessdata.fda.gov
Suction Control, Intracardiac, Cardiopulmonary Bypass	DWD	2	Manufacturer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Manufacturer	accessdata.fda.gov
Tubing, Fluid Delivery	FPK	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
December 18, 2024	K241058	Lyka® PORT Needle Free Access Device (4170Y)	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
June 5, 2022	K213846	Q2 Blood Administration Sets	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
June 2, 2022	K213588	Q2 IV Administration Sets	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
January 21, 2021	K202672	Precision Delivery Infusion Set	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
November 20, 2020	K201984	MPS 3 ND Myocardial Protection System	DTR	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
June 19, 2020	K200438	MPS 3 Myocardial Protection System	DTR	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
October 1, 2018	K173716	MPS2 Myocardial Protection System Console	DTR	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
March 8, 2017	K162804	Q2 Low Pressure Power Injection Extension Set	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
December 6, 2016	K162304	Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
September 30, 2015	K151079	Q2 Intravenous Adminstration Sets and Extension Sets	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
October 19, 2012	K113867	LACRICATH LACRIMAL DUCT CATHETER	OKS	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
July 31, 2012	K113118	STENTUBE LACRIMAL INTUBATION SET	OKS	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
May 10, 2006	K061143	ROBERTSITE STOPCOCK	FMG	Substantially Equivalent	Halkey-Roberts Corp.	accessdata.fda.gov
September 2, 2004	K041979	MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260	DTR	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
April 7, 2004	K040385	MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
March 6, 2001	K002689	SWABSITE SWABBABLE VALVE, MODEL 245000	FPA	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
September 18, 2000	K002366	QUEST MPS BACK-UP SYSYEM	DWF	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
November 6, 1997	K971928	QUEST VESSEL CATHETER	DWF	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
March 6, 1996	K953838	MYOCARDIAL PROTECTION SYSTEM	DTR	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
February 12, 1993	K922356	FLOW CONTROL VALVE, CAT. NO. ACV-38	MJJ	Substantially Equivalent	American Omni Medical, Inc.	accessdata.fda.gov
January 6, 1987	K864503	MODIFIED RLV-2100 B	DWD	Substantially Equivalent	American Omni Medical, Inc.	accessdata.fda.gov
May 14, 1980	K800825	EXTENSION SET QUEST CODE #3000	FPK	Substantially Equivalent	Quest Medical, Inc.	accessdata.fda.gov
December 9, 1976	K760894	VACUUM RELIEF VALVE	DWD	Substantially Equivalent	Delta Medical Industries	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 14, 2023	93116	Class II	Ongoing	Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection site	For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.	accessdata.fda.gov
December 23, 2022	91409	Class II	Ongoing	Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2	Delivery Sets may have tubing that could become detached that could result in patient infection.	accessdata.fda.gov
December 17, 2019	85389	Class II	Terminated	Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top cover	Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical interven	accessdata.fda.gov
October 28, 2015	72524	Class II	Terminated	Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for u	The products have been found to intermittently exhibit a seal failure during use.	accessdata.fda.gov
February 26, 2015	70633	Class II	Terminated	LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.	Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels	accessdata.fda.gov
July 29, 2010	57141	Not yet classified	Terminated	Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest	User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.	accessdata.fda.gov
May 23, 2003	26429	Not yet classified	Terminated	Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes	Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2024. 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.