Quest Medical, Inc.
Medical device manufacturer in Allen, TX.
39510(k) clearances
0PMA approvals
6recalls
Device types
- FPA Set, Administration, Intravascular 12
- DWF Catheter, Cannula And Tubing, Vascular… 8
- DTR Heat-Exchanger, Cardiopulmonary Bypass 5
- LDR Controller, Infusion, Intravascular… 2
- FRN Pump, Infusion 2
- OKS Lacrimal Stents And Intubation Sets 2
- FOZ Catheter, Intravascular, Therapeutic… 1
- FPK Tubing, Fluid Delivery 1
- JCY Catheter, Infusion 1
- DQX Wire, Guide, Catheter 1
- BTC Bag, Reservoir 1
- JKA Tubes, Vials, Systems, Serum Separators… 1
- DTL Adaptor, Stopcock, Manifold, Fitting… 1
- MJJ Cpb Check Valve, Retrograde Flow, In-Line 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y)FPA · Traditional | 12/18/2024SE |
| K213846 | Q2 Blood Administration SetsFPA · Traditional | 06/05/2022SE |
| K213588 | Q2 IV Administration SetsFPA · Traditional | 06/02/2022SE |
| K202672 | Precision Delivery Infusion SetFPA · Traditional | 01/21/2021SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | 06/19/2020SE |
| K182442 | MiniGuard Arterial Safety ValveMJJ · Traditional | 11/06/2018SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | 10/01/2018SE |
| K162804 | Q2 Low Pressure Power Injection Extension SetFPA · Traditional | 03/08/2017SE |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…FPA · Traditional | 12/06/2016SE |
| K151079 | Q2 Intravenous Adminstration Sets and Extension SetsFPA · Traditional | 09/30/2015SE |
| K113867 | Lacricath Lacrimal Duct CatheterOKS · Traditional | 10/19/2012SE |
| K113118 | Stentube Lacrimal Intubation SetOKS · Special | 07/31/2012SE |
| K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260DTR · Special | 09/02/2004SE |
| K040385 | Multiport Manifold Set with Swabable Valves, Model 9900FPA · Abbreviated | 04/07/2004SE |
| K002689 | Swabsite Swabbable Valve, Model 245000FPA · Traditional | 03/06/2001SE |
| K002366 | Quest MPS Back-Up SysyemDWF · Traditional | 09/18/2000SE |
| K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)FRN · Traditional | 05/31/2000SE |
| K971928 | Quest Vessel CatheterDWF · Traditional | 11/06/1997SE |
| K955818 | Foamseal Retrograde Cardioplegia CatheterDWF · Traditional | 03/26/1996SE |
| K953838 | Myocardial Protection SystemDTR · Traditional | 03/06/1996SE |
| K952531 | Quest Vein Graft Perfusion SetDTL · Traditional | 08/24/1995SE |
| K951088 | Quest Retrograde Cardiplegia Cannula-RccsDWF · Traditional | 06/14/1995SE |
| K950814 | Quest Antegrade Cardioplegia CannulaDWF · Traditional | 05/25/1995SE |
| K941916 | Quest Coronary Sinus Perfusion Cannula -FrccDWF · Traditional | 04/06/1995SE |
| K941166 | Quest Coronary Sinus Perfusion CannulaDWF · Traditional | 01/17/1995SE |
| K925049 | Quest Heart Insulation PadDWF · Traditional | 02/01/1994SE |
| K860157 | Nitroglycerin Intravascular Administration SetFPA · Traditional | 04/09/1986SE |
| K851017 | Quest 521 Variable Pressure Volumetric Infusion PuFRN · Traditional | 05/07/1985SE |
| K841361 | Syringe Additive IV Admin. SetsFPA · Traditional | 05/21/1984SE |
| K834528 | Model 2001 Intelligent InfusorLDR · Traditional | 02/21/1984SE |
| K830472 | LiposolJKA · Traditional | 06/08/1983SE |
| K823404 | Volumeric ControllerLDR · Traditional | 12/22/1982SE |
| K822216 | Volumetric ControllerBTC · Traditional | 08/16/1982SE |
| K820699 | Catheter Guide WireDQX · Traditional | 04/09/1982SE |
| K813606 | Silicone Elastomer Infusion CatheterJCY · Traditional | 01/18/1982SE |
| K811685 | I.V. Administration SetFPA · Traditional | 06/30/1981SE |
| K800825 | Extension Set Quest Code #3000FPK · Traditional | 05/14/1980SE |
| K800786 | Injection Site, Code No. 3100FOZ · Traditional | 05/08/1980SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0197-2024 Class II | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic…For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and… | 07/14/2023Open, Classified |
| Z-1100-2023 Class II | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with…Delivery Sets may have tubing that could become detached that could result in patient infection. | 12/23/2022Open, Classified |
| Z-2107-2020 Class II | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7…Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS… | 12/17/2019Terminated |
| Z-0361-2016 Class II | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger…The products have been found to intermittently exhibit a seal failure during use. | 10/28/2015Terminated |
| Z-1368-2015 Class II | 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 | 02/26/2015Terminated |
| Z-1924-2011 | Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software…User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. | 07/29/2010Terminated |