# Edan Instruments, Inc.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 94 (2004–2026): 94 510(k) clearances
- Product codes: DPS (19), MHX (17), IYN (13), HGM (12), IYO (7), DQA (6), KNG (6), ITX (2), DXN (2), MWI (2), DQK (2), IPF (1)
- 510(k) review time since 2016: median 190 days, against 177 for FDA's reviews in the same codes and years (22 of 49 faster)
- Predicates its devices cite: 157 (84 its own); citations of its devices by later devices: 131 (84 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 17 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- General Electric Medical Systems Information Techn: 6 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: 3 (https://510kreport.com/company/philips-medizinsysteme-boeblingen-cardiac-an)
- Imex Medical Systems, Inc.: 3 (https://510kreport.com/company/imex-medical-systems)
- Ge Medical Systems Information Technologies: 3 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Ge Medical Systems Ultrasound and Primary Care Dia: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-dia)
- APK Technology Co., Ltd.: 2 (https://510kreport.com/company/apk-technology)
- ZOLL Medical Corporation: 2 (https://510kreport.com/company/zoll-medical)

## Firms that cite its devices most
- Advanced Instrumentations, Inc.: 12 (https://510kreport.com/company/advanced-instrumentations)
- Caf Medical Solutions, Inc.: 4 (https://510kreport.com/company/caf-medical-solutions)
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-biocare-bio-medical-equipment)
- Medisono, LLC: 3 (https://510kreport.com/company/medisono)
- Guangdong Biolight Meditech Co., Ltd.: 2 (https://510kreport.com/company/guangdong-biolight-meditech)
- Shenzhen Creative Industry Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-creative-industry)
- Advanced Instruments, Inc.: 2 (https://510kreport.com/company/advanced-instruments)
- Spacelabs Healthcare: 2 (https://510kreport.com/company/spacelabs-healthcare)

## Its most-cited devices
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), cited by 7
- K083821: Vital Signs Monitor (2009), cited by 5
- K040480: Sonotrax Ultrasonic Pocket Doppler (2004), cited by 5
- K123249: Diagnostic Ultrasound System (2013), cited by 5
- K092010: PC Ecg, Model SE-1010 (2009), cited by 5
- K131971: IM60/IM70 Patient Monitor (2014), cited by 4

## Recent decisions
- K251508: Telemetry Monitor (iT30, iT50) (Aug 6, 2026)
- K252463: SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (Jul 2, 2026)
- K251591: Holter ECG and ABP system (HolterABP) (Feb 9, 2026)
- K251268: Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (Dec 23, 2025)
- K241882: Fetal & Maternal Monitor (F15A, F15A Air) (Aug 27, 2025)
- K250179: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (Jul 29, 2025)
- 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) (Feb 20, 2025)
- K240320: Patient Monitor (RespArray) (Jun 28, 2024)

Source page: https://510kreport.com/company/edan-instruments