Quest Medical, Inc.
FDA Regulatory Profile
Quest Medical, Inc. appears in FDA public data with 5 recalls, 39 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0197-2024, Class II) was initiated on July 14, 2023. Its most recent 510(k) clearance was granted on December 18, 2024.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 39
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0197-2024 | Class II | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid | July 14, 2023 |
| Z-1100-2023 | Class II | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, RE | December 23, 2022 |
| Z-2107-2020 | Class II | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)29091 | December 17, 2019 |
| Z-0361-2016 | Class II | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delive | October 28, 2015 |
| Z-1368-2015 | Class II | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures. | February 26, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | December 18, 2024 |
| K213846 | Q2 Blood Administration Sets | June 5, 2022 |
| K213588 | Q2 IV Administration Sets | June 2, 2022 |
| K202672 | Precision Delivery Infusion Set | January 21, 2021 |
| K201984 | MPS 3 ND Myocardial Protection System | November 20, 2020 |
| K200438 | MPS 3 Myocardial Protection System | June 19, 2020 |
| K182442 | MiniGuard Arterial Safety Valve | November 6, 2018 |
| K173716 | MPS2 Myocardial Protection System Console | October 1, 2018 |
| K162804 | Q2 Low Pressure Power Injection Extension Set | March 8, 2017 |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, | December 6, 2016 |
| K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | September 30, 2015 |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | October 19, 2012 |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | July 31, 2012 |
| K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | September 2, 2004 |
| K040385 | MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 | April 7, 2004 |
| K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 | March 6, 2001 |
| K002366 | QUEST MPS BACK-UP SYSYEM | September 18, 2000 |
| K994274 | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) | May 31, 2000 |
| K971928 | QUEST VESSEL CATHETER | November 6, 1997 |
| K955818 | FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER | March 26, 1996 |