Edan Instruments, Inc.
Shenzhen Guangdong, CN
EDAN INSTRUMENTS, INC. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 94 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for Edan Instruments, Inc. between 2004 and 2026. The busiest year on record is 2017, with 10. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 7 |
| 2010 | 8 |
| 2011 | 4 |
| 2012 | 6 |
| 2013 | 5 |
| 2014 | 2 |
| 2015 | 6 |
| 2016 | 9 |
| 2017 | 10 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 4 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50) | MHX | Substantially Equivalent | |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | DPS | Substantially Equivalent | |
| K251591 | Holter ECG and ABP system (HolterABP) | DQK | Substantially Equivalent | |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | IYN | Substantially Equivalent | |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | HGM | Substantially Equivalent | |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | MHX | Substantially Equivalent | |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | IYN | Substantially Equivalent | |
| K240320 | Patient Monitor (RespArray) | MHX | Substantially Equivalent | |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | IPF | Substantially Equivalent | |
| K232962 | Patient Monitor (iX10, iX12, iX15) | MHX | Substantially Equivalent | |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | MWI | Substantially Equivalent | |
| K232694 | Central Monitoring System (MFM-CMS) | MHX | Substantially Equivalent | |
| K230184 | Holter ECG and ABP System | DSH | Substantially Equivalent | |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | DPS | Substantially Equivalent | |
| K220308 | Patient Monitor: RespArray | MHX | Substantially Equivalent | |
| K212278 | Electrocardiograph | DPS | Substantially Equivalent | |
| K210140 | electrocardiograph: SE-1202 | DPS | Substantially Equivalent | |
| K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | DXN | Substantially Equivalent | |
| K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | MWI | Substantially Equivalent | |
| K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 | IYN | Substantially Equivalent | |
| K202336 | Patient Monitor | MHX | Substantially Equivalent | |
| K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K192514 | Patient Monitor | MHX | Substantially Equivalent | |
| K192791 | Diagnostic Ultrasound System | IYO | Substantially Equivalent | |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | IYO | Substantially Equivalent | |
| K180380 | vital signs monitor | DQA | Substantially Equivalent | |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | HGM | Substantially Equivalent | |
| K172780 | SD1 Ultrasonic Pocket Doppler | KNG | Substantially Equivalent | |
| K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K180408 | U60 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K171942 | Electrocardiograph | DPS | Substantially Equivalent | |
| K173003 | U50 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K172380 | U2 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K171943 | Electrocardiograph | DPS | Substantially Equivalent | |
| K171178 | Central Monitoring System | HGM | Substantially Equivalent | |
| K171900 | Acclarix AX4 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System | IYO | Substantially Equivalent | |
| K170995 | Electrocardiograph | DPS | Substantially Equivalent | |
| K160876 | PC ECG | DPS | Substantially Equivalent | |
| K161056 | Telemetry Transmitter | MHX | Substantially Equivalent | |
| K162055 | Acclarix LX8 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K160981 | Patient Monitor | MHX | Substantially Equivalent | |
| K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control | CHL | Substantially Equivalent | |
| K161302 | PC ECG | DPS | Substantially Equivalent | |
| K161300 | Acclarix AX8 Diagnostic Ultrasound System | IYO | Substantially Equivalent | |
| K152552 | Patient Monitor | MHX | Substantially Equivalent | |
| K160790 | Acclarix LX8 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K152427 | PC ECG | DPS | Substantially Equivalent | |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | KNG | Substantially Equivalent | |
| K151787 | Holter System | DQK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003971136 | 3003971136 | EDAN INSTRUMENTS, INC. | #15 Jinhui Road, Jinsha Community, Shenzhen Guangdong 518122 CN | 2026 | and 46 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- JIXCalibrator, Multi-Analyte Mixture
- HEXColposcope (And Colpomicroscope)
- PTZColposcope (And Colpomicroscope), Exempt
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- GLKControl, Hematocrit
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- GXYElectrode, Cutaneous
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- DPWFlowmeter, Blood, Cardiovascular
- GKFInstrument, Hematocrit, Automated
- OUGMedical Device Data System
- HEPMonitor, Blood-Flow, Ultrasonic
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MAAMonitor, Fetal Doppler Ultrasound
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- KNGMonitor, Ultrasonic, Fetal
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- DQAOximeter
- DSBPlethysmograph, Impedance
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- BZKSpirometer, Monitoring (W/Wo Alarm)
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- HFNTransducer, Pressure, Intrauterine
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- IOLTreadmill, Powered
- DYCVectorcardiograph
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0041-2012 | ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box. | The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain