# Bionet Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 14 (2001–2023): 14 510(k) clearances
- Names in FDA's records: Bionet Co., Ltd. (11); Bionet Company, Ltd. (3)
- Product codes: DPS (5), LOS (3), HGM (2), MWI (1), BZG (1), HEP (1), IYN (1)
- 510(k) review time since 2016: median 251 days, against 236 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 18 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guangzhou Sonostar Technologies Co., Ltd.: 2 (https://510kreport.com/company/guangzhou-sonostar-technologies)
- Healcerion Co., Ltd.: 2 (https://510kreport.com/company/healcerion)
- Goldway Us, Inc.: 1 (https://510kreport.com/company/goldway-us)
- Caird Technology: 1 (https://510kreport.com/company/caird-technology)
- Benson Medical Instruments Co.: 1 (https://510kreport.com/company/benson-medical-instruments)
- Micromedical, Inc.: 1 (https://510kreport.com/company/micromedical)
- Analogic Corp.: 1 (https://510kreport.com/company/analogic)
- Imex Medical Systems, Inc.: 1 (https://510kreport.com/company/imex-medical-systems)

## Firms that cite its devices most
- Sunray Medical Apparatus Co., Ltd.: 2 (https://510kreport.com/company/sunray-medical-apparatus)
- Noblitt & Rueland: 1 (https://510kreport.com/company/noblitt-rueland)

## Its most-cited devices
- K220535: Cardio10 (2022), cited by 2
- K082008: Bionet BM3PLUS Patient Monitor (2008), cited by 1
- K130322: SPM-300 (2013), cited by 1
- K011328: Cardio Care Ekg-2000 12-Channel Electrocardiograph (2001), cited by 1
- K043598: FC 1400 Fetal Monitor (2005), cited by 1
- K113306: Cardio 7 (2012), cited by 1

## Recent decisions
- K231160: Cardio Q50, Cardio Q70 (Dec 15, 2023)
- K231150: Cardio P1 (Nov 9, 2023)
- K220535: Cardio10 (Nov 15, 2022)
- K220169: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (Oct 11, 2022)
- K130322: SPM-300 (Nov 15, 2013)
- K113306: Cardio 7 (Jul 16, 2012)
- K102767: Cardio XP (Jun 3, 2011)
- K090895: Ekg-Plus II Software (Aug 26, 2009)

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