Company ยท CN
Edan Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (4 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DPS | Electrocardiograph | 20 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 17 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 13 |
| HGM | System, Monitoring, Perinatal | 12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 |
| DQA | Oximeter | 6 |
| KNG | Monitor, Ultrasonic, Fetal | 6 |
| DQK | Computer, Diagnostic, Programmable | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| HEP | Monitor, Blood-Flow, Ultrasonic | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 |
| IPF | Stimulator, Muscle, Powered | 1 |
| MAA | Monitor, Fetal Doppler Ultrasound | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2026 | K251508 | Telemetry Monitor (iT30, iT50) Edan Instruments, Inc., CN | MHX |
| Jul 2, 2026 | K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) Edan Instruments, Inc., CN | DPS |
| Feb 9, 2026 | K251591 | Holter ECG and ABP system (HolterABP) Edan Instruments, Inc., CN | DQK |
| Dec 23, 2025 | K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) Edan Instruments, Inc., CN | IYN |
| Aug 27, 2025 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) Edan Instruments, Inc., CN | HGM |
| Jul 29, 2025 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) Edan Instruments, Inc., CN | MHX |
| Feb 20, 2025 | K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Accla Edan Instruments, Inc., CN | IYN |
| Jun 28, 2024 | K240320 | Patient Monitor (RespArray) Edan Instruments, Inc., CN | MHX |
| May 16, 2024 | K232786 | Stimulation System (PA series, PR series, S series and Q series) Edan Instruments, Inc., CN | IPF |
| Apr 19, 2024 | K232962 | Patient Monitor (iX10, iX12, iX15) Edan Instruments, Inc., CN | MHX |
| Mar 8, 2024 | K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s Edan Instruments, Inc., CN | MWI |
| Feb 5, 2024 | K232694 | Central Monitoring System (MFM-CMS) Edan Instruments, Inc., CN | MHX |
| Sep 25, 2023 | K230184 | Holter ECG and ABP System Edan Instruments, Inc., CN | DSH |
| Jul 28, 2023 | K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro Edan Instruments, Inc., CN | DPS |
| Aug 11, 2022 | K220308 | Patient Monitor: RespArray Edan Instruments, Inc., CN | MHX |
| Apr 7, 2022 | K212278 | Electrocardiograph Edan Instruments, Inc., CN | DPS |
| Oct 1, 2021 | K210140 | electrocardiograph: SE-1202 Edan Instruments, Inc., CN | DPS |
| Oct 1, 2021 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 Edan Instruments, Inc., CN | DXN |
| Jan 28, 2021 | K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s Edan Instruments, Inc., CN | MWI |
| Jan 25, 2021 | K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Edan Instruments, Inc., CN | IYN |
| Jan 23, 2021 | K202336 | Patient Monitor Edan Instruments, Inc., CN | MHX |
| May 21, 2020 | K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Apr 2, 2020 | K192514 | Patient Monitor Edan Instruments, Inc., CN | MHX |
| Nov 27, 2019 | K192791 | Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYO |
| Mar 28, 2019 | K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYO |
| Dec 21, 2018 | K180380 | vital signs monitor Edan Instruments, Inc., CN | DQA |
| Aug 30, 2018 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 Edan Instruments, Inc., CN | HGM |
| Jun 6, 2018 | K172780 | SD1 Ultrasonic Pocket Doppler Edan Instruments, Inc., CN | KNG |
| May 24, 2018 | K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Apr 13, 2018 | K180408 | U60 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Jan 24, 2018 | K171942 | Electrocardiograph Edan Instruments, Inc., CN | DPS |
| Nov 15, 2017 | K173003 | U50 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Sep 29, 2017 | K172380 | U2 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Sep 25, 2017 | K171943 | Electrocardiograph Edan Instruments, Inc., CN | DPS |
| Sep 6, 2017 | K171178 | Central Monitoring System Edan Instruments, Inc., CN | HGM |
| Aug 18, 2017 | K171900 | Acclarix AX4 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Jul 18, 2017 | K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYO |
| Jun 2, 2017 | K170995 | Electrocardiograph Edan Instruments, Inc., CN | DPS |
| Feb 15, 2017 | K160876 | PC ECG Edan Instruments, Inc., CN | DPS |
| Feb 3, 2017 | K161056 | Telemetry Transmitter Edan Instruments, Inc., CN | MHX |
| Jan 31, 2017 | K162055 | Acclarix LX8 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Dec 22, 2016 | K160981 | Patient Monitor Edan Instruments, Inc., CN | MHX |
| Jul 15, 2016 | K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Cont Edan Instruments, Inc., CN | CHL |
| Jul 1, 2016 | K161302 | PC ECG Edan Instruments, Inc., CN | DPS |
| May 31, 2016 | K161300 | Acclarix AX8 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYO |
| Apr 29, 2016 | K152552 | Patient Monitor Edan Instruments, Inc., CN | MHX |
| Apr 4, 2016 | K160790 | Acclarix LX8 Diagnostic Ultrasound System Edan Instruments, Inc., CN | IYN |
| Feb 5, 2016 | K152427 | PC ECG Edan Instruments, Inc., CN | DPS |
| Jan 29, 2016 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler Edan Instruments, Inc., CN | KNG |
| Jan 27, 2016 | K151787 | Holter System Edan Instruments, Inc., CN | DQK |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2011 | Edan Instruments, Inc. 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 Terminated |
DPS | K091513 |