# Wuxi Hisky Medical Technologies Co., Ltd.

- Location (FDA's records): Wuxi, CN
- FDA decisions: 5 (2018–2025): 5 510(k) clearances
- Product codes: IYO (3), IYN (1), OWN (1)
- 510(k) review time since 2016: median 213 days, against 124 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 3 (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
- Echosens: 2 (https://510kreport.com/company/echosens)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Mauna Kea Technologies: 1 (https://510kreport.com/company/mauna-kea-technologies)

## Its most-cited devices
- K200136: Shear Wave Quantificational Ultrasound Diagnostic System (2020), cited by 2
- K173595: Shear Wave Quantificational Ultrasound Diagnostic System (2018), cited by 1

## Recent decisions
- K250026: Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (Oct 1, 2025)
- K243711: Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (Jul 24, 2025)
- K243880: Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (Jun 17, 2025)
- K200136: Shear Wave Quantificational Ultrasound Diagnostic System (Mar 17, 2020)
- K173595: Shear Wave Quantificational Ultrasound Diagnostic System (Jun 22, 2018)

Source page: https://510kreport.com/company/wuxi-hisky-medical-technologies