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Quest Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
39
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0197-2024Class IIQ2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid July 14, 2023
Z-1100-2023Class IIPrecision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REDecember 23, 2022
Z-2107-2020Class IIRef 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)29091December 17, 2019
Z-0361-2016Class IIModel 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. deliveOctober 28, 2015
Z-1368-2015Class IILIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.February 26, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K241058Lyka® PORT Needle Free Access Device (4170Y)December 18, 2024
K213846Q2 Blood Administration SetsJune 5, 2022
K213588Q2 IV Administration SetsJune 2, 2022
K202672Precision Delivery Infusion SetJanuary 21, 2021
K201984MPS 3 ND Myocardial Protection SystemNovember 20, 2020
K200438MPS 3 Myocardial Protection SystemJune 19, 2020
K182442MiniGuard Arterial Safety ValveNovember 6, 2018
K173716MPS2 Myocardial Protection System ConsoleOctober 1, 2018
K162804Q2 Low Pressure Power Injection Extension SetMarch 8, 2017
K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, December 6, 2016
K151079Q2 Intravenous Adminstration Sets and Extension SetsSeptember 30, 2015
K113867LACRICATH LACRIMAL DUCT CATHETEROctober 19, 2012
K113118STENTUBE LACRIMAL INTUBATION SETJuly 31, 2012
K041979MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260September 2, 2004
K040385MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900April 7, 2004
K002689SWABSITE SWABBABLE VALVE, MODEL 245000March 6, 2001
K002366QUEST MPS BACK-UP SYSYEMSeptember 18, 2000
K994274QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)May 31, 2000
K971928QUEST VESSEL CATHETERNovember 6, 1997
K955818FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETERMarch 26, 1996