Medical device manufacturer
Edan Instruments, Inc.
Edan Instruments, Inc. holds 93 FDA 510(k) clearances across 17 product codes. Median elapsed review time is 119 days. openFDA lists 1 recall record naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 93
- Product codes
- 17
- Median review
- 119 days
- Recall records
- 1
How does FDA spell Edan Instruments, Inc.?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| EDAN INSTRUMENTS, INC. | device/registrationlisting | normalised |
| Edan Instruments, Inc. | device/recall | normalised |
| Edan Instruments, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Edan Instruments, Inc. file in?
17 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DPS | Electrocardiograph | 19 | 110 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 16 | 188 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 13 | 58 days | |
| HGM | System, Monitoring, Perinatal | 12 | 138 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 50 days | |
| DQA | Oximeter | 6 | 90 days | |
| KNG | Monitor, Ultrasonic, Fetal | 6 | 60 days | |
| DQK | Computer, Diagnostic, Programmable | 2 | 210 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 27 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 9 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 122 days | |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 364 days | |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 245 days | |
| HEP | Monitor, Blood-Flow, Ultrasonic | 1 | 29 days | |
| HEX | Colposcope (And Colpomicroscope) | 1 | 145 days | |
| IPF | Stimulator, Muscle, Powered | 1 | 248 days | |
| MAA | Monitor, Fetal Doppler Ultrasound | 1 | 90 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Edan Instruments, Inc. had a recall?
openFDA lists 1 recall record naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0041-2012TerminatedDPS
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.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Edan Instruments, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | DPS | 330 | |
| K251591 | Holter ECG and ABP system (HolterABP) | DQK | 262 | |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | IYN | 243 | |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | HGM | 425 | |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | MHX | 188 | |
| 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 | 27 | |
| K240320 | Patient Monitor (RespArray) | MHX | 147 | |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | IPF | 248 | |
| K232962 | Patient Monitor (iX10, iX12, iX15) | MHX | 211 | |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | MWI | 165 |
Source: openFDA device/510k · retrieved
Where is Edan Instruments, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Edan Instruments, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.