Data / Medical devices / China / Edan Instruments, Inc.
Edan Instruments, Inc.: FDA-registered device maker in Shenzhen Guangdong, China, 61 510(k) clearances
Edan Instruments, Inc. is registered with the FDA (registration 3003971136) in Shenzhen Guangdong, China. It lists 56 device types. The FDA files 61 510(k) clearances under its listings, the newest dated August 6, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003971136
- Address
- #15 Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan District, Shenzhen Guangdong, China, 518122
- Owner or operator
- EDAN INSTRUMENTS, INC. (9055347)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 4, 2009
- Registered through
- 2027
- Brand names listed
- Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix AX4 Diagnostic Ultrasound System, Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78,, Acclarix AX8 Exp, Acclarix AX8 Super,, Acclarix AX8, Acclarix AX7 Diagnostic Ultrasound System, Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88., Acclarix LX9 Series Diagnostic Ultrasound System, Ambulatory Blood Pressure Monitor Model : SA-05, SA-06, SA-08, SA-09, SA-10 and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2026 | K251508 | Telemetry Monitor (iT30, iT50) | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| July 2, 2026 | K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 9, 2026 | K251591 | Holter ECG and ABP system (HolterABP) | DQK | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| December 23, 2025 | K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 27, 2025 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| July 29, 2025 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 20, 2025 | 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 | Edan Instruments, Inc. | accessdata.fda.gov |
| June 28, 2024 | K240320 | Patient Monitor (RespArray) | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| May 16, 2024 | K232786 | Stimulation System (PA series, PR series, S series and Q series) | IPF | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| April 19, 2024 | K232962 | Patient Monitor (iX10, iX12, iX15) | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| March 8, 2024 | K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | MWI | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 5, 2024 | K232694 | Central Monitoring System (MFM-CMS) | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| September 25, 2023 | K230184 | Holter ECG and ABP System | DSH | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| July 28, 2023 | K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 11, 2022 | K220308 | Patient Monitor: RespArray | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| April 7, 2022 | K212278 | Electrocardiograph | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| October 1, 2021 | K210140 | electrocardiograph: SE-1202 | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| October 1, 2021 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | DXN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| January 28, 2021 | K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | MWI | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| January 25, 2021 | 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 | Edan Instruments, Inc. | accessdata.fda.gov |
| January 23, 2021 | K202336 | Patient Monitor | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| May 21, 2020 | K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| April 2, 2020 | K192514 | Patient Monitor | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| November 27, 2019 | K192791 | Diagnostic Ultrasound System | IYO | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| March 28, 2019 | K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | IYO | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| December 21, 2018 | K180380 | vital signs monitor | DQA | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 30, 2018 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| June 6, 2018 | K172780 | SD1 Ultrasonic Pocket Doppler | KNG | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| May 24, 2018 | K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| April 13, 2018 | K180408 | U60 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| January 24, 2018 | K171942 | Electrocardiograph | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| November 15, 2017 | K173003 | U50 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| September 29, 2017 | K172380 | U2 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| September 25, 2017 | K171943 | Electrocardiograph | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| September 6, 2017 | K171178 | Central Monitoring System | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 18, 2017 | K171900 | Acclarix AX4 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| June 2, 2017 | K170995 | Electrocardiograph | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 3, 2017 | K161056 | Telemetry Transmitter | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| December 22, 2016 | K160981 | Patient Monitor | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| July 15, 2016 | 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 | Edan Instruments, Inc. | accessdata.fda.gov |
| July 1, 2016 | K161302 | PC ECG | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| April 29, 2016 | K152552 | Patient Monitor | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 5, 2016 | K152427 | PC ECG | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| January 29, 2016 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | KNG | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| January 27, 2016 | K151787 | Holter System | DQK | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| July 1, 2015 | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 6, 2015 | K140579 | ULTRASONIC POCKET DOPPLER | KNG | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| March 20, 2014 | K131971 | IM60/IM70 PATIENT MONITOR | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 25, 2014 | K131503 | SE-601 SERIES ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| September 17, 2013 | K131830 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | IYO | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131818 | VITAL SIGNS MONITOR | DQA | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| June 21, 2013 | K120727 | MFM-CMS CENTRAL MONITORING SYSTEM | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| March 16, 2012 | K120188 | ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 6, 2012 | K113653 | PATIENT MONITOR | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 1, 2012 | K113623 | PATIENT MONITOR | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| July 20, 2011 | K110922 | PATIENT MONITOR | MHX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| January 13, 2011 | K102140 | FETAL MONITORS, MODELS F2 AND F3 | HGM | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| November 24, 2010 | K101539 | VITAL SIGNS MONITOR MODEL M3B | DQA | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| August 10, 2010 | K101960 | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER | HEP | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| December 3, 2009 | K092727 | H100B PULSE OXIMETER | DQA | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| June 19, 2009 | K091680 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | ITX | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 10, 2010 | 59418 | Not yet classified | Terminated | 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 ele | 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. | accessdata.fda.gov |
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Updated August 6, 2026. 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.