# Goldway Us, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 4 (2003–2012): 4 510(k) clearances
- Names in FDA's records: Goldway Us, Inc. (2); Goldway (Us), Inc. (2)
- Product codes: MWI (3), HEX (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 11 (3 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
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Leica Microscopy Systems, Ltd.: 1 (https://510kreport.com/company/leica-microscopy-systems)
- Leisegang Medical, Inc.: 1 (https://510kreport.com/company/leisegang-medical)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)

## Firms that cite its devices most
- Shenzhen Comen Medical Instruments Co.,Ltd: 1 (https://510kreport.com/company/shenzhen-comen-medical-instruments)
- Infinium Medical: 1 (https://510kreport.com/company/infinium-medical)
- Bionet Co., Ltd.: 1 (https://510kreport.com/company/bionet)
- Forth Photonics Hellas SA: 1 (https://510kreport.com/company/forth-photonics-hellas)
- Xuzhou Kernel Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/xuzhou-kernel-medical-equipment)
- Medgyn Products, Inc.: 1 (https://510kreport.com/company/medgyn-products)
- Shenzhen Goldcare Meditech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-goldcare-meditech)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)

## Its most-cited devices
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 (2003), cited by 5
- K021154: Goldway Patient Monitor, Model # UT4000F (2003), cited by 4
- K112877: Comen Multi-Parameter Patient Monitor (2012), cited by 1
- K033988: Goldway UT4000A Vital Signs Monitor (2004), cited by 1

## Recent decisions
- K112877: Comen Multi-Parameter Patient Monitor (Nov 7, 2012)
- K033988: Goldway UT4000A Vital Signs Monitor (Feb 25, 2004)
- K021154: Goldway Patient Monitor, Model # UT4000F (Apr 11, 2003)
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 (Feb 10, 2003)

Source page: https://510kreport.com/company/goldway-us