510(k) Report

FDA applicant

Edan Instruments, Inc.

Shenzhen, CN94 decisions2004–202620 recalls

FDA records 94 decisions for Edan Instruments, Inc. (Shenzhen, CN) from 2004 to 2026: 94 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 190 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 157 predicates, 84 of them its own earlier devices. 20 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Edan Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2007: 12008: 32009: 72010: 82011: 42012: 62013: 52014: 22015: 62016: 92017: 102018: 62019: 22020: 22021: 52022: 22023: 22024: 52025: 42026 (partial year): 3
2007high 10 (2017) · low 1 (2007)2026

2026 so far, outlined.

Recalls per year

16in 2025

2010: 22016: 12017: 12025: 16
2007high 16 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Edan Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Edan Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DPSElectrocardiograph19decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)17decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic13decisions
  • HGMSystem, Monitoring, Perinatal12decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic7decisions
  • DQAOximeter6decisions

Also: KNG (6), ITX (2), DXN (2), MWI (2), DQK (2), IPF (1).

How long do its 510(k) reviews take?

Since 2016, its 49 510(k)s took a median of 190 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 22 of its 49 were faster than that.

Whose devices does it build on?

Its devices cite 157 predicates; 84 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 131 times; 84 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and…Edan Instruments, Inc. · 20097cite it
  • K083821Vital Signs MonitorEdan Instruments, Inc. · 20095cite it
  • K040480Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 20045cite it
  • K123249Diagnostic Ultrasound SystemEdan Instruments, Inc. · 20135cite it
  • K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 20095cite it
  • K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 20144cite it

What has FDA decided for it lately?

  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026
  • K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
  • K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc. · 2025
  • K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
  • K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc. · 2025
  • K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix…Edan Instruments, Inc. · 2025
  • K240320Patient Monitor (RespArray)Edan Instruments, Inc. · 2024

All 94 as Edan Instruments, Inc. →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K131818Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product…Oct 24, 2025Class II
  • K102140Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product…Oct 24, 2025Class II
  • K232962Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15…Oct 24, 2025Class II
  • K152552Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product…Oct 24, 2025Class II
  • K101539Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product…Oct 24, 2025Class II
  • K202892Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As…Oct 24, 2025Class II