Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Quest Medical, Inc. · Predicate Candidate Screening
39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
300 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 | 244 | 0 |
| K213846 | Q2 Blood Administration Sets | Quest Medical, Inc. | 2022-06-05 | 177 | 0 |
| K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | 2022-06-02 | 202 | 0 |
| K202672 | Precision Delivery Infusion Set | Quest Medical, Inc. | 2021-01-21 | 128 | 1 |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020-11-20 | 126 | 0 |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020-06-19 | 116 | 0 |
| K182442 | MiniGuard Arterial Safety Valve | Quest Medical, Inc. | 2018-11-06 | 60 | 0 |
| K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018-10-01 | 300 | 0 |
| K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017-03-08 | 154 | 0 |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Chec | Quest Medical, Inc. | 2016-12-06 | 111 | 0 |
| K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | Quest Medical, Inc. | 2015-09-30 | 161 | 1 |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | Quest Medical, Inc. | 2012-10-19 | 294 | 0 |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | Quest Medical, Inc. | 2012-07-31 | 284 | 0 |
| K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201 | Quest Medical, Inc. | 2004-09-02 | 41 | 1 |
| K040385 | MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 | Quest Medical, Inc. | 2004-04-07 | 50 | 0 |
| K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 | Quest Medical, Inc. | 2001-03-06 | 189 | 0 |
| K002366 | QUEST MPS BACK-UP SYSYEM | Quest Medical, Inc. | 2000-09-18 | 53 | 0 |
| K994274 | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS ( | Quest Medical, Inc. | 2000-05-31 | 163 | 0 |
| K971928 | QUEST VESSEL CATHETER | Quest Medical, Inc. | 1997-11-06 | 163 | 0 |
| K955818 | FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER | Quest Medical, Inc. | 1996-03-26 | 91 | 0 |
| K953838 | MYOCARDIAL PROTECTION SYSTEM | Quest Medical, Inc. | 1996-03-06 | 203 | 3 |
| K952531 | QUEST VEIN GRAFT PERFUSION SET | Quest Medical, Inc. | 1995-08-24 | 84 | 0 |
| K951088 | QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS | Quest Medical, Inc. | 1995-06-14 | 97 | 0 |
| K950814 | QUEST ANTEGRADE CARDIOPLEGIA CANNULA | Quest Medical, Inc. | 1995-05-25 | 92 | 0 |
| K941916 | QUEST CORONARY SINUS PERFUSION CANNULA -FRCC | Quest Medical, Inc. | 1995-04-06 | 352 | 0 |
| K941166 | QUEST CORONARY SINUS PERFUSION CANNULA | Quest Medical, Inc. | 1995-01-17 | 312 | 0 |
| K925049 | QUEST HEART INSULATION PAD | Quest Medical, Inc. | 1994-02-01 | 483 | 0 |
| K860157 | NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET | Quest Medical, Inc. | 1986-04-09 | 83 | 0 |
| K851017 | QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU | Quest Medical, Inc. | 1985-05-07 | 56 | 0 |
| K841361 | SYRINGE ADDITIVE IV ADMIN. SETS | Quest Medical, Inc. | 1984-05-21 | 49 | 0 |
| K834528 | MODEL 2001 INTELLIGENT INFUSOR | Quest Medical, Inc. | 1984-02-21 | 62 | 0 |
| K830472 | LIPOSOL | Quest Medical, Inc. | 1983-06-08 | 113 | 0 |
| K823404 | VOLUMERIC CONTROLLER | Quest Medical, Inc. | 1982-12-22 | 37 | 0 |
| K822216 | VOLUMETRIC CONTROLLER | Quest Medical, Inc. | 1982-08-16 | 21 | 0 |
| K820699 | CATHETER GUIDE WIRE | Quest Medical, Inc. | 1982-04-09 | 25 | 0 |
| K813606 | SILICONE ELASTOMER INFUSION CATHETER | Quest Medical, Inc. | 1982-01-18 | 20 | 0 |
| K811685 | I.V. ADMINISTRATION SET | Quest Medical, Inc. | 1981-06-30 | 15 | 0 |
| K800825 | EXTENSION SET QUEST CODE #3000 | Quest Medical, Inc. | 1980-05-14 | 30 | 0 |
| K800786 | INJECTION SITE, CODE NO. 3100 | Quest Medical, Inc. | 1980-05-08 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda