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Data / Medical devices / United States / MHC Medical Products

MHC Medical Products: FDA-registered device maker in Fairfield, OH, United States, 28 510(k) clearances

MHC Medical Products is registered with the FDA (registration 3005798905) in Fairfield, OH, United States. It lists 15 device types. The FDA files 28 510(k) clearances under its listings, the newest dated October 14, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 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.

Get makers like this oneWatch MHC Medical Products
FDA registration number
3005798905
Address
8695 Seward Road, Fairfield, OH, United States, 45011
Owner or operator
MHC Medical Products, LLC (9096130)
Roles
Complaint file establishment, Specification developer
First device listed
July 9, 2009
Registered through
2026
Brand names listed
EasyTouch Lancets, EasyTouch Safety Lancets

Devices it lists

DeviceProduct codeClassRoleSource
Container, SharpsMMK2Complaint file establishmentaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Complaint file establishmentaccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Complaint file establishmentaccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Complaint file establishmentaccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Complaint file establishmentaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Complaint file establishment, Specification developeraccessdata.fda.gov
OximeterDQA2Complaint file establishmentaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Complaint file establishmentaccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Complaint file establishmentaccessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureQRK2Complaint file establishmentaccessdata.fda.gov
Syringe, AntistickMEG2Complaint file establishmentaccessdata.fda.gov
Syringe, PistonFMF2Complaint file establishment, Specification developeraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishmentaccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Complaint file establishmentaccessdata.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
October 14, 2025K252637Community Containers (Flap and Daisy)MMKSubstantially EquivalentKeter Canada, Inc.accessdata.fda.gov
May 2, 2025K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist BlooDXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
April 30, 2025K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);DXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
December 1, 2022K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GDXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
November 30, 2022K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceQRLSubstantially EquivalentShandong Lianfa Medical Plastic Products Co. , Ltd.accessdata.fda.gov
October 3, 2022K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)FMKSubstantially EquivalentShandong Lianfa Medical Plastic Products Co. , Ltd.accessdata.fda.gov
September 7, 2022K222034RightLance Blood Lancing SystemQRLSubstantially EquivalentBeijing Ruicheng Medical Supplies Co., Ltd.accessdata.fda.gov
March 4, 2022K210216Disposable Automatically Retractable Insulin Safety SyringeMEGSubstantially EquivalentShantou Wealy Medical Instrument Co.,Ltdaccessdata.fda.gov
February 18, 2022K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EDXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
October 16, 2020K201396Finetest Lite Smart Blood Glucose Monitoring SystemNBWSubstantially EquivalentOsang Healthcare Co. , Ltd.accessdata.fda.gov
March 12, 2019K181447Safety insulin needle for single useFMISubstantially EquivalentBerpu Medical Technology Co., Ltd.accessdata.fda.gov
November 28, 2018K180207Non-contact Infrared ThermometerFLLSubstantially EquivalentAlicn Medical (Shenzhen), Inc.accessdata.fda.gov
August 9, 2018K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single UseMEGSubstantially EquivalentBerpu Medical Technology Co., Ltd.accessdata.fda.gov
August 3, 2018K163578EasyTouch Safety Pen NeedleFMISubstantially EquivalentMhc Medical Products, LLCaccessdata.fda.gov
December 29, 2016K162180Disposable Insulin SyringeFMFSubstantially EquivalentBerpu Medical Technology Co., Ltd.accessdata.fda.gov
December 4, 2014K141105PULSE OXIMETERDQASubstantially EquivalentHunan Accurate Bio-Medical Technology Co., Ltd.accessdata.fda.gov
November 19, 2014K141640AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLEMEGSubstantially EquivalentShantou Wealy Medical Instrument Co.,Ltdaccessdata.fda.gov
November 20, 2013K130230STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLESFMFSubstantially EquivalentWuxi Yushou Medical Applicances Co., Ltd.accessdata.fda.gov
November 20, 2013K130212SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGEFMISubstantially EquivalentWuxi Yushou Medical Applicances Co., Ltd.accessdata.fda.gov
July 13, 2012K113192HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially EquivalentInfopia Co, Ltd.accessdata.fda.gov
December 23, 2011K112789EASY TOUCHFMISubstantially EquivalentMhc Medical Products, LLCaccessdata.fda.gov
September 2, 2010K102178EASY TOUCHFMFSubstantially EquivalentMhc Medical Productsaccessdata.fda.gov
September 4, 2009K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGESMEGSubstantially EquivalentInviro Medical Devices, Inc.accessdata.fda.gov
September 4, 2009K091434TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63MDXNSubstantially EquivalentTruly Instrument Co., Ltd.accessdata.fda.gov
September 4, 2009K091415TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702MDXNSubstantially EquivalentTruly Instrument Co., Ltd.accessdata.fda.gov
July 9, 2009K091474EASY.TOUCH INSULIN SYRINGEFMFSubstantially EquivalentMasters Healthcare, LLCaccessdata.fda.gov
April 8, 2008K073492DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially EquivalentTyson Bioresearch, Inc.accessdata.fda.gov
August 11, 2006K053519SAFETY SYRINGEMEGSubstantially EquivalentWuxi Yushou Medical Applicances Co., Ltd.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
April 6, 201879950Class IIOngoingEasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLYThe retail shelf cartons may be labeled with an incorrect lot number.accessdata.fda.gov

Compare with other makers

Updated October 14, 2025. 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.