Edan Instruments, Inc.: FDA clearances and approvals
Edan Instruments, Inc. has 94 FDA 510(k) clearances (first 2004, latest 2026), across 17 product codes in 6 review panels. Median 510(k) review time: 120 days. Since 2017 its median was 190 days, against 138 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Edan Instruments, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 54 |
| 2013 | 5 | 114 |
| 2014 | 2 | 271 |
| 2015 | 6 | 120 |
| 2016 | 9 | 163 |
| 2017 | 10 | 74 |
| 2018 | 6 | 238 |
| 2019 | 2 | 56 |
| 2020 | 2 | 218 |
| 2021 | 5 | 159 |
| 2022 | 2 | 226 |
| 2023 | 2 | 276 |
| 2024 | 5 | 165 |
| 2025 | 4 | 216 |
| 2026 | 3 | 330 |
Review time against the same product codes
Since 2017, Edan Instruments, Inc.'s cleared 510(k)s took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 19 | 19 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 17 | 17 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 13 | 13 |
| HGM | System, Monitoring, Perinatal | 12 | 12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 7 |
| DQA | Oximeter | 6 | 6 |
| KNG | Monitor, Ultrasonic, Fetal | 6 | 6 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
Plus 7 more product codes.
Review panels
- Cardiovascular (43)
- Radiology (23)
- Obstetrics and Gynecology (20)
- Anesthesiology (6)
- Clinical Chemistry (1)
- Physical Medicine (1)
Most recent Edan Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50) | MHX | 2026-08-06 | 447 |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | DPS | 2026-07-02 | 330 |
| K251591 | Holter ECG and ABP system (HolterABP) | DQK | 2026-02-09 | 262 |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | IYN | 2025-12-23 | 243 |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | HGM | 2025-08-27 | 425 |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | MHX | 2025-07-29 | 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 | 2025-02-20 | 27 |
| K240320 | Patient Monitor (RespArray) | MHX | 2024-06-28 | 147 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | IPF | 2024-05-16 | 248 |
| K232962 | Patient Monitor (iX10, iX12, iX15) | MHX | 2024-04-19 | 211 |
84 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-09-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Edan Instruments, Inc. have?
Edan Instruments, Inc. has 94 FDA 510(k) clearances (first 2004, latest 2026), across 17 product codes in 6 review panels.
How long does FDA take to clear Edan Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Edan Instruments, Inc.'s cleared 510(k)s is 120 days. Since 2017: 190 days, versus 138 days for all cleared 510(k)s in the same product codes.
What devices does Edan Instruments, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 19); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 17); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 13).
Has Edan Instruments, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Edan Instruments, Inc; the most recent began 2010-09-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 94 Edan Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Edan Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.