# Mediana Co., Ltd.

- Location (FDA's records): Wonju-Si, KR
- FDA decisions: 10 (2005–2020): 10 510(k) clearances
- Product codes: DXN (4), MHX (2), KNG (1), HGM (1), FLL (1), DQA (1)
- 510(k) review time since 2016: median 322 days, against 179 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 30 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Omron Healthcare, Inc.: 3 (https://510kreport.com/company/omron-healthcare)
- Welch Allyn Protocol, Inc.: 3 (https://510kreport.com/company/welch-allyn-protocol)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Spacelabs Medical, Inc.: 2 (https://510kreport.com/company/spacelabs-medical)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Tyco Healthcare Group LP: 1 (https://510kreport.com/company/tyco-healthcare-group)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)

## Its most-cited devices
- K152659: V10 (2016), cited by 1
- K170497: V10 (2017), cited by 1
- K100217: Lucon M-Series Patient Monitor, Models M20 and M30 (2010), cited by 1
- K051375: Vital Signs Monitor (2005), cited by 1
- K100225: Pulse Oximeter Model P10 (2011), cited by 1

## Recent decisions
- K200434: V20, V20a, AVSM3 SNF (Oct 9, 2020)
- K170497: V10 (Dec 15, 2017)
- K160358: DT-100 (Feb 24, 2017)
- K152659: V10 (Aug 25, 2016)
- K112190: Patient Monitor (Nov 9, 2011)
- K110612: FM20 (Nov 8, 2011)
- K110630: F10 (Jun 24, 2011)
- K100225: Pulse Oximeter Model P10 (Feb 9, 2011)

Source page: https://510kreport.com/company/mediana