# Bistos Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 11 (2005–2025): 11 510(k) clearances
- Product codes: HGM (5), HGX (3), QGL (1), LBI (1), FMZ (1)
- 510(k) review time since 2016: median 212 days, against 122 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 8 (4 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
- Biosys Co., Ltd.: 2 (https://510kreport.com/company/biosys)
- Neurosigma, Inc.: 1 (https://510kreport.com/company/neurosigma)
- Medela AG: 1 (https://510kreport.com/company/medela)
- Koven Technology, Inc.: 1 (https://510kreport.com/company/koven-technology)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)
- Medical Select, Inc.: 1 (https://510kreport.com/company/medical-select)
- Atom Medical Corporation: 1 (https://510kreport.com/company/atom-medical)

## Firms that cite its devices most
- Haenim Co., Ltd.: 1 (https://510kreport.com/company/haenim)
- Gerium Medical, Ltd.: 1 (https://510kreport.com/company/gerium-medical)
- Thera B Medical Products: 1 (https://510kreport.com/company/thera-b-medical-products)
- Mediana Co., Ltd.: 1 (https://510kreport.com/company/mediana)

## Its most-cited devices
- K200675: Hi bebe super (Models BT-150S and BT-150L) (2021), cited by 2
- K052190: Fetal Monitor, Models BT-300 and BT-200 (2005), cited by 2
- K210289: Infant Phototherapy Equipment (2021), cited by 2
- K160274: Hi bebe plus (2016), cited by 1
- K100885: Fetal Monitor Model: BT-200T (2010), cited by 1

## Recent decisions
- K251512: Hi bebe super (BT-150B) (Sep 25, 2025)
- K232991: BT-1000 (Aug 28, 2024)
- K210289: Infant Phototherapy Equipment (May 28, 2021)
- K200675: Hi bebe super (Models BT-150S and BT-150L) (Feb 10, 2021)
- K160274: Hi bebe plus (Sep 1, 2016)
- K142799: Model BT-220L and BT-220C (Jul 9, 2015)
- K132543: Infant Incubator (Jul 3, 2014)
- K121267: BT-200V Vascular Doppler (Aug 2, 2012)

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