Quest Medical, Inc
Allen, TX, US
QUEST MEDICAL, INC. appears in FDA device records in Allen, TX. FDA records list 39 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 39 510(k) clearances for Quest Medical, Inc between 1980 and 2024. The busiest year on record is 1995, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 4 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 1 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 2 |
| 1997 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2004 | 2 |
| 2012 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | FPA | Substantially Equivalent | |
| K213846 | Q2 Blood Administration Sets | FPA | Substantially Equivalent | |
| K213588 | Q2 IV Administration Sets | FPA | Substantially Equivalent | |
| K202672 | Precision Delivery Infusion Set | FPA | Substantially Equivalent | |
| K201984 | MPS 3 ND Myocardial Protection System | DTR | Substantially Equivalent | |
| K200438 | MPS 3 Myocardial Protection System | DTR | Substantially Equivalent | |
| K182442 | MiniGuard Arterial Safety Valve | MJJ | Substantially Equivalent | |
| K173716 | MPS2 Myocardial Protection System Console | DTR | Substantially Equivalent | |
| K162804 | Q2 Low Pressure Power Injection Extension Set | FPA | Substantially Equivalent | |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets | FPA | Substantially Equivalent | |
| K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | FPA | Substantially Equivalent | |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | OKS | Substantially Equivalent | |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | OKS | Substantially Equivalent | |
| K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | DTR | Substantially Equivalent | |
| K040385 | MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 | FPA | Substantially Equivalent | |
| K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 | FPA | Substantially Equivalent | |
| K002366 | QUEST MPS BACK-UP SYSYEM | DWF | Substantially Equivalent | |
| K994274 | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) | FRN | Substantially Equivalent | |
| K971928 | QUEST VESSEL CATHETER | DWF | Substantially Equivalent | |
| K955818 | FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER | DWF | Substantially Equivalent | |
| K953838 | MYOCARDIAL PROTECTION SYSTEM | DTR | Substantially Equivalent | |
| K952531 | QUEST VEIN GRAFT PERFUSION SET | DTL | Substantially Equivalent | |
| K951088 | QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS | DWF | Substantially Equivalent | |
| K950814 | QUEST ANTEGRADE CARDIOPLEGIA CANNULA | DWF | Substantially Equivalent | |
| K941916 | QUEST CORONARY SINUS PERFUSION CANNULA -FRCC | DWF | Substantially Equivalent | |
| K941166 | QUEST CORONARY SINUS PERFUSION CANNULA | DWF | Substantially Equivalent | |
| K925049 | QUEST HEART INSULATION PAD | DWF | Substantially Equivalent | |
| K860157 | NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K851017 | QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU | FRN | Substantially Equivalent | |
| K841361 | SYRINGE ADDITIVE IV ADMIN. SETS | FPA | Substantially Equivalent | |
| K834528 | MODEL 2001 INTELLIGENT INFUSOR | LDR | Substantially Equivalent | |
| K830472 | LIPOSOL | JKA | Substantially Equivalent | |
| K823404 | VOLUMERIC CONTROLLER | LDR | Substantially Equivalent | |
| K822216 | VOLUMETRIC CONTROLLER | BTC | Substantially Equivalent | |
| K820699 | CATHETER GUIDE WIRE | DQX | Substantially Equivalent | |
| K813606 | SILICONE ELASTOMER INFUSION CATHETER | JCY | Substantially Equivalent | |
| K811685 | I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K800825 | EXTENSION SET QUEST CODE #3000 | FPK | Substantially Equivalent | |
| K800786 | INJECTION SITE, CODE NO. 3100 | FOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1649914 | 3001665800 | QUEST MEDICAL, INC. | 1 Allentown Pkwy, ALLEN, TX 75002 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- PUKAdministration Set Securement Device
- BTCBag, Reservoir
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- JCYCatheter, Infusion
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LDRController, Infusion, Intravascular, Electronic
- DWCController, Temperature, Cardiopulmonary Bypass
- MJJCpb Check Valve, Retrograde Flow, In-Line
- KRLDetector, Bubble, Cardiopulmonary Bypass
- KMKDevice, Intravascular Catheter Securement
- HNWDilator, Lachrymal
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- HNQHook, Ophthalmic
- DWSInstruments, Surgical, Cardiovascular
- OKSLacrimal Stents And Intubation Sets
- HNLProbe, Lachrymal
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- GAESnare, Surgical
- FOXStand, Infusion
- FMGStopcock, I.V. Set
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
- DRSTransducer, Blood-Pressure, Extravascular
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- FPKTubing, Fluid Delivery
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0197-2024 | 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 sites, drip chamber and roller clamps. | 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. | Class II | Open, Classified | |
| Z-1100-2023 | 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. | Class II | Open, Classified | |
| Z-2107-2020 | 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 covers) | 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 intervention. | Class II | Terminated | |
| Z-0361-2016 | 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 use with cardiopulmonary bypass equipment. | The products have been found to intermittently exhibit a seal failure during use. | Class II | Terminated | |
| Z-1368-2015 | 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 | Class II | Terminated | |
| Z-1924-2011 | 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 agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery. | User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. | Terminated | ||
| Z-1037-03 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain