# Shenzhen Creative Industry Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 11 (2007–2021): 11 510(k) clearances
- Product codes: DQA (7), MWI (2), KNG (1), DSH (1)
- 510(k) review time since 2016: median 242 days, against 190 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 15 (8 its own); citations of its devices by later devices: 15 (8 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)
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Nonin Medical, Inc.: 1 (https://510kreport.com/company/nonin-medical)
- Oridion Capnography, Inc.: 1 (https://510kreport.com/company/oridion-capnography)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)

## Firms that cite its devices most
- Vocare, Inc.: 1 (https://510kreport.com/company/vocare)
- Shenzhen Mericonn Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mericonn-technology)
- Cmi Health, Inc.: 1 (https://510kreport.com/company/cmi-health)
- Shenzhen Witleaf Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-witleaf-medical-electronics)
- North-Vision Tech., Inc.: 1 (https://510kreport.com/company/north-vision-tech)
- Wellvii, Inc.: 1 (https://510kreport.com/company/wellvii)
- Cosinuss GmbH: 1 (https://510kreport.com/company/cosinuss)

## Its most-cited devices
- K123711: Patient Monitor (2013), cited by 4
- K170047: All-in-One Health Monitor, PC-303 (2017), cited by 3
- K063641: PC-60, Non-Invasivepulse Oximeter (2007), cited by 2
- K093016: Vital Signs Monitor (2010), cited by 2
- K201468: Pulse Oximeter (2021), cited by 2
- K172792: Handheld Pulse Oximeter, Model SP-20 (2018), cited by 1

## Recent decisions
- K201468: Pulse Oximeter (Jan 25, 2021)
- K192343: Patient Monitor (Dec 31, 2019)
- K172792: Handheld Pulse Oximeter, Model SP-20 (Nov 13, 2018)
- K170047: All-in-One Health Monitor, PC-303 (Sep 9, 2017)
- K150093: Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 (Jun 3, 2015)
- K123711: Patient Monitor (Oct 1, 2013)
- K120502: PC-60NW Fingertip Oximeter (Dec 7, 2012)
- K093016: Vital Signs Monitor (Mar 30, 2010)

Source page: https://510kreport.com/company/shenzhen-creative-industry