# Orantech, Inc.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 5 (2018–2019): 5 510(k) clearances
- Product codes: CCK (1), DXQ (1), DSA (1), FLL (1), DQA (1)
- 510(k) review time since 2016: median 323 days, against 225 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 2 (0 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
- Unimed Medical Supplies, Inc.: 2 (https://510kreport.com/company/unimed-medical-supplies)
- Respironics Novametrix, Inc.: 1 (https://510kreport.com/company/respironics-novametrix)
- Shenzhen Med-Link Electronics Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-med-link-electronics-tech)
- Shenzhen Caremed Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-caremed-medical-technology)

## Firms that cite its devices most
- Shenzhen Coreray Technology, Ltd.: 1 (https://510kreport.com/company/shenzhen-coreray-technology)
- Shenzhen Sino-K Medical Technology Co.,Ltd: 1 (https://510kreport.com/company/shenzhen-sino-k-medical-technology)

## Its most-cited devices
- K173197: Reusable NIBP Cuff (2018), cited by 1
- K181270: Disposable SpO2 Sensors, Reusable SpO2 Sensors (2018), cited by 1

## Recent decisions
- K182327: Patient Cables and Leadwires , Disposable ECG Leadwires (Jan 30, 2019)
- K173194: Temperature Probe (Oct 10, 2018)
- K181270: Disposable SpO2 Sensors, Reusable SpO2 Sensors (Sep 7, 2018)
- K173197: Reusable NIBP Cuff (Aug 21, 2018)
- K171828: ETCO2 Sensor (May 31, 2018)

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