# Shenzhen Comen Medical Instruments Co.,Ltd

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 5 (2018–2025): 5 510(k) clearances
- Product codes: MHX (4), JOW (1)
- 510(k) review time since 2016: median 283 days, against 192 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 1 (1 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.: 3 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Goldway Us, Inc.: 1 (https://510kreport.com/company/goldway-us)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- K191106: C50 and C80 Multi-parameter Patient Monitor (2019), cited by 1

## Recent decisions
- K250854: Multi-parameter Patient Monitor (N10);  Multi-parameter Patient Monitor (N12);  Multi-parameter Patient Monitor (N15);  Multi-parameter Patient Monitor (N10MPro);  Multi-parameter Patient Monitor (N12MPro);  Multi-parameter Patient Monitor (N15MPro) (Dec 17, 2025)
- K250190: Sequential Compression System (SCD600) (Dec 8, 2025)
- K211619: Multi-Parameter Patient Monitor (Dec 29, 2022)
- K191106: C50 and C80 Multi-parameter Patient Monitor (Dec 13, 2019)
- K173454: Multi-parameter Patient Monitor, models C30 (Aug 16, 2018)

Source page: https://510kreport.com/company/shenzhen-comen-medical-instruments