Company · US
Quest Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2024. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 14 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 9 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 8 |
| FRN | Pump, Infusion | 2 |
| LDR | Controller, Infusion, Intravascular, Electronic | 2 |
| OKS | Lacrimal Stents And Intubation Sets | 2 |
| BTC | Bag, Reservoir | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPK | Tubing, Fluid Delivery | 1 |
| HNL | Probe, Lachrymal | 1 |
| JCY | Catheter, Infusion | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2024 | K241058 | Lyka® PORT Needle Free Access Device (4170Y) Quest Medical, Inc. | FPA |
| Jun 5, 2022 | K213846 | Q2 Blood Administration Sets Quest Medical, Inc. | FPA |
| Jun 2, 2022 | K213588 | Q2 IV Administration Sets Quest Medical, Inc. | FPA |
| Jan 21, 2021 | K202672 | Precision Delivery Infusion Set Quest Medical, Inc. | FPA |
| Nov 20, 2020 | K201984 | MPS 3 ND Myocardial Protection System Quest Medical, Inc. | DTR |
| Jun 19, 2020 | K200438 | MPS 3 Myocardial Protection System Quest Medical, Inc. | DTR |
| Nov 6, 2018 | K182442 | MiniGuard Arterial Safety Valve Quest Medical, Inc. | MJJ |
| Oct 1, 2018 | K173716 | MPS2 Myocardial Protection System Console Quest Medical, Inc. | DTR |
| Mar 8, 2017 | K162804 | Q2 Low Pressure Power Injection Extension Set Quest Medical, Inc. | FPA |
| Dec 6, 2016 | K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets Quest Medical, Inc. | FPA |
| Sep 30, 2015 | K151079 | Q2 Intravenous Adminstration Sets and Extension Sets Quest Medical, Inc. | FPA |
| Oct 19, 2012 | K113867 | LACRICATH LACRIMAL DUCT CATHETER Quest Medical, Inc. | OKS |
| Jul 31, 2012 | K113118 | STENTUBE LACRIMAL INTUBATION SET Quest Medical, Inc. | OKS |
| Sep 2, 2004 | K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 Quest Medical, Inc. | DTR |
| Apr 7, 2004 | K040385 | MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 Quest Medical, Inc. | FPA |
| Mar 6, 2001 | K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 Quest Medical, Inc. | FPA |
| Sep 18, 2000 | K002366 | QUEST MPS BACK-UP SYSYEM Quest Medical, Inc. | DWF |
| May 31, 2000 | K994274 | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) Quest Medical, Inc. | FRN |
| Nov 6, 1997 | K971928 | QUEST VESSEL CATHETER Quest Medical, Inc. | DWF |
| Mar 26, 1996 | K955818 | FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER Quest Medical, Inc. | DWF |
| Mar 6, 1996 | K953838 | MYOCARDIAL PROTECTION SYSTEM Quest Medical, Inc. | DTR |
| Aug 24, 1995 | K952531 | QUEST VEIN GRAFT PERFUSION SET Quest Medical, Inc. | DTL |
| Jun 14, 1995 | K951088 | QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS Quest Medical, Inc. | DWF |
| May 25, 1995 | K950814 | QUEST ANTEGRADE CARDIOPLEGIA CANNULA Quest Medical, Inc. | DWF |
| Apr 6, 1995 | K941916 | QUEST CORONARY SINUS PERFUSION CANNULA -FRCC Quest Medical, Inc. | DWF |
| Jan 17, 1995 | K941166 | QUEST CORONARY SINUS PERFUSION CANNULA Quest Medical, Inc. | DWF |
| Feb 1, 1994 | K925049 | QUEST HEART INSULATION PAD Quest Medical, Inc. | DWF |
| Apr 9, 1986 | K860157 | NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET Quest Medical, Inc. | FPA |
| May 7, 1985 | K851017 | QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU Quest Medical, Inc. | FRN |
| May 21, 1984 | K841361 | SYRINGE ADDITIVE IV ADMIN. SETS Quest Medical, Inc. | FPA |
| Feb 21, 1984 | K834528 | MODEL 2001 INTELLIGENT INFUSOR Quest Medical, Inc. | LDR |
| Jun 8, 1983 | K830472 | LIPOSOL Quest Medical, Inc. | JKA |
| Dec 22, 1982 | K823404 | VOLUMERIC CONTROLLER Quest Medical, Inc. | LDR |
| Aug 16, 1982 | K822216 | VOLUMETRIC CONTROLLER Quest Medical, Inc. | BTC |
| Apr 9, 1982 | K820699 | CATHETER GUIDE WIRE Quest Medical, Inc. | DQX |
| Jan 18, 1982 | K813606 | SILICONE ELASTOMER INFUSION CATHETER Quest Medical, Inc. | JCY |
| Jun 30, 1981 | K811685 | I.V. ADMINISTRATION SET Quest Medical, Inc. | FPA |
| May 14, 1980 | K800825 | EXTENSION SET QUEST CODE #3000 Quest Medical, Inc. | FPK |
| May 8, 1980 | K800786 | INJECTION SITE, CODE NO. 3100 Quest Medical, Inc. | FOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2023 | Quest Medical, Inc. 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 needl Open, Classified |
FPA | K151079 |
| Feb 7, 2023 | Quest Medical, Inc. Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 Open, Classified |
FPA | K202672 |
| Dec 17, 2019 | Quest Medical, Inc. 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 Terminated |
DTR | K173716 |
| Dec 2, 2015 | Quest Medical, Inc. 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 Volum Terminated |
DTR | K953838 |
| Apr 2, 2015 | Quest Medical, Inc. LIS27T - Lacrimal Intubation Set RX Only Sterile
Used in various ophthalmology procedures. Terminated |
HNL | None listed |
| Apr 8, 2011 | Quest Medical, Inc 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 Terminated |
DTR | K041979 K953838 |
| Jul 22, 2003 | Quest Medical, Inc Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes Terminated |
DWF | K953838 |