Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Edan Instruments, Inc. — Predicate Candidate Screening
94 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
312 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026-08-06 | 447 | 0 |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026-07-02 | 330 | 0 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 | 262 | 0 |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12 | Edan Instruments, Inc. | 2025-12-23 | 243 | 0 |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025-08-27 | 425 | 0 |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025-07-29 | 188 | 0 |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acc | Edan Instruments, Inc. | 2025-02-20 | 27 | 0 |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024-06-28 | 147 | 0 |
| K232786 | Stimulation System (PA series, PR series, S series and Q ser | Edan Instruments, Inc. | 2024-05-16 | 248 | 0 |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024-04-19 | 211 | 1 |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2024-03-08 | 165 | 1 |
| K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024-02-05 | 153 | 1 |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | 2023-09-25 | 245 | 0 |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023-07-28 | 308 | 0 |
| K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022-08-11 | 190 | 0 |
| K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022-04-07 | 261 | 0 |
| K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA- | Edan Instruments, Inc. | 2021-10-01 | 255 | 0 |
| K210140 | electrocardiograph: SE-1202 | Edan Instruments, Inc. | 2021-10-01 | 255 | 0 |
| K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2021-01-28 | 122 | 1 |
| K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix | Edan Instruments, Inc. | 2021-01-25 | 119 | 0 |
| K202336 | Patient Monitor | Edan Instruments, Inc. | 2021-01-23 | 159 | 1 |
| K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Ser | Edan Instruments, Inc. | 2020-05-21 | 234 | 0 |
| K192514 | Patient Monitor | Edan Instruments, Inc. | 2020-04-02 | 203 | 1 |
| K192791 | Diagnostic Ultrasound System | Edan Instruments, Inc. | 2019-11-27 | 58 | 0 |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Dia | Edan Instruments, Inc. | 2019-03-28 | 55 | 0 |
| K180380 | vital signs monitor | Edan Instruments, Inc. | 2018-12-21 | 312 | 1 |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Expr | Edan Instruments, Inc. | 2018-08-30 | 336 | 2 |
| K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2018-06-06 | 265 | 0 |
| K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diag | Edan Instruments, Inc. | 2018-05-24 | 52 | 0 |
| K180408 | U60 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2018-04-13 | 58 | 0 |
| K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018-01-24 | 210 | 0 |
| K173003 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-11-15 | 49 | 0 |
| K172380 | U2 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-09-29 | 53 | 0 |
| K171943 | Electrocardiograph | Edan Instruments, Inc. | 2017-09-25 | 89 | 0 |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017-09-06 | 138 | 1 |
| K171900 | Acclarix AX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-08-18 | 53 | 0 |
| K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diag | Edan Instruments, Inc. | 2017-07-18 | 29 | 0 |
| K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017-06-02 | 60 | 0 |
| K160876 | PC ECG | Edan Instruments, Inc. | 2017-02-15 | 322 | 0 |
| K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017-02-03 | 295 | 2 |
| K162055 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-01-31 | 190 | 0 |
| K160981 | Patient Monitor | Edan Instruments, Inc. | 2016-12-22 | 259 | 1 |
| K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 C | Edan Instruments, Inc. | 2016-07-15 | 364 | 0 |
| K161302 | PC ECG | Edan Instruments, Inc. | 2016-07-01 | 53 | 0 |
| K161300 | Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016-05-31 | 22 | 0 |
| K152552 | Patient Monitor | Edan Instruments, Inc. | 2016-04-29 | 234 | 1 |
| K160790 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016-04-04 | 13 | 0 |
| K152427 | PC ECG | Edan Instruments, Inc. | 2016-02-05 | 163 | 0 |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016-01-29 | 58 | 0 |
| K151787 | Holter System | Edan Instruments, Inc. | 2016-01-27 | 210 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda