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Data / Medical devices / United States / DRE Med

DRE Med: FDA-registered device maker in Louisville, KY, United States, 29 510(k) clearances

DRE Med is registered with the FDA (registration 1000122786) in Louisville, KY, United States. It lists 50 device types. The FDA files 29 510(k) clearances under its listings, the newest dated April 19, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
1000122786
Address
2601 Stanley Gault PKWY, Louisville, KY, United States, 40223
Owner or operator
DRE Resume LLC (10092249)
Roles
Repackager or relabeler
First device listed
December 17, 2024
Registered through
2026
Brand names listed
AV-S Anesthesia Ventilator, DRE Adana Surgical Table, DRE Avela Procedure Chair, DRE Blood Pressure Cuff, DRE Citadel 200 Electrosurgical Unit, DRE Citadel EZ Electrosurgical Unit, DRE Citadel Trio Electrosurgical Unit, DRE Comfort Series Warmer and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Repackager or relabeleraccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Repackager or relabeleraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Repackager or relabeleraccessdata.fda.gov
Camera, Television, Surgical, Without AudioFWB1Repackager or relabeleraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Repackager or relabeleraccessdata.fda.gov
Chair And Table, MedicalKMN1Repackager or relabeleraccessdata.fda.gov
Computer, Blood-PressureDSK2Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Repackager or relabeleraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Repackager or relabeleraccessdata.fda.gov
ElectrocardiographDPS2Repackager or relabeleraccessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)MWJ2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Repackager or relabeleraccessdata.fda.gov
Incubator, NeonatalFMZ2Repackager or relabeleraccessdata.fda.gov
Lamp, SurgicalFTD2Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Repackager or relabeleraccessdata.fda.gov
Light, Surgical, FiberopticFST2Repackager or relabeleraccessdata.fda.gov
Monitor, Blood-Flow, UltrasonicHEP2Repackager or relabeleraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Repackager or relabeleraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Repackager or relabeleraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Repackager or relabeleraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Repackager or relabeleraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Repackager or relabeleraccessdata.fda.gov
Monitor, Ultrasonic, FetalKNG2Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Repackager or relabeleraccessdata.fda.gov
Stretcher, WheeledFPO2Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Repackager or relabeleraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Repackager or relabeleraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Repackager or relabeleraccessdata.fda.gov
System, Thermal RegulatingDWJ2Repackager or relabeleraccessdata.fda.gov
Table, Examination, Medical, PoweredLGX1Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, ManualFSE1Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, PneumaticFWW1Repackager or relabeleraccessdata.fda.gov
Transducer, Ultrasonic, ObstetricHGL2Repackager or relabeleraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Repackager or relabeleraccessdata.fda.gov
Warmer, Irrigation SolutionLHC1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 19, 2024K232962Patient Monitor (iX10, iX12, iX15)MHXSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
February 5, 2024K232694Central Monitoring System (MFM-CMS)MHXSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
October 5, 2022K220138Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HPGEISubstantially EquivalentLed Spaaccessdata.fda.gov
August 30, 2018K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3HGMSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
January 24, 2018K171942ElectrocardiographDPSSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
September 6, 2017K171178Central Monitoring SystemHGMSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
April 28, 2017K162679IOB Temperature Management SystemDWJSubstantially EquivalentIob Medical, Inc.accessdata.fda.gov
February 5, 2016K152427PC ECGDPSSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
January 27, 2016K151787Holter SystemDQKSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
May 15, 2015K143728Minhua Disposable Blood Pressure CuffDXQSubstantially EquivalentSuzhou Minhua Medical Apparatusaccessdata.fda.gov
February 6, 2015K142244CLEO PATIENT MONITORMWISubstantially EquivalentInfinium Medicalaccessdata.fda.gov
August 7, 2014K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHTFSYSubstantially EquivalentMedical Illumination International, Inc.accessdata.fda.gov
July 3, 2014K132543INFANT INCUBATORFMZSubstantially EquivalentBistos Co., Ltd.accessdata.fda.gov
March 20, 2014K131971IM60/IM70 PATIENT MONITORMHXSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
February 25, 2014K131503SE-601 SERIES ELECTROCARDIOGRAPHDPSSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
August 30, 2013K131818VITAL SIGNS MONITORDQASubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
June 2, 2011K103737OMNI II PATIENT MONITORMWISubstantially EquivalentInfinium Medicalaccessdata.fda.gov
January 13, 2011K102140FETAL MONITORS, MODELS F2 AND F3HGMSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
November 23, 2010K103268OMNI EXPRESSMWISubstantially EquivalentInfinium Medicalaccessdata.fda.gov
August 11, 2010K101052OMNI III PATIENT MONITORMWISubstantially EquivalentInfinium Medicalaccessdata.fda.gov
August 10, 2010K101960SONOTRAX SERIES ULTRASONIC POCKET DOPPLERHEPSubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
June 22, 2010K10038821ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSFSTSubstantially EquivalentMedical Illumination International, Inc.accessdata.fda.gov
December 3, 2009K092727H100B PULSE OXIMETERDQASubstantially EquivalentEdan Instruments, Inc.accessdata.fda.gov
June 13, 2008K080609SWC/DWC WARMING CABINETSLHCSubstantially EquivalentMac Medicalaccessdata.fda.gov
July 28, 2006K061102PRIMA ANAESTHESIA MACHINEBSZSubstantially EquivalentPenlon , Ltd.accessdata.fda.gov
September 23, 2005K051222AV-S ANAESTHESIA VENTILATORCBKSubstantially EquivalentPenlon Limitedaccessdata.fda.gov
February 12, 1999K982371MEDCO ASPIRATOR IVBTASubstantially EquivalentMedco Mfg.accessdata.fda.gov
April 1, 1998K971749EASYGO ASPIRATORBTASubstantially EquivalentPrecision Medical, Inc.accessdata.fda.gov
October 7, 1993K932494PM PUMP ASPIRATORBTASubstantially EquivalentPrecision Medical, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 15, 202392448Class IIOngoingPhilips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrDevices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.accessdata.fda.gov

Compare with other makers

Updated April 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.