# Suntech Medical, Inc.

- Location (FDA's records): Morrisville, NC
- FDA decisions: 8 (2005–2016): 8 510(k) clearances
- Names in FDA's records: Suntech Medical, Inc. (7); Suntech Medical (1)
- Product codes: DXN (6), DXQ (2)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Suntech Medical Instruments, Inc.: 3 (https://510kreport.com/company/suntech-medical-instruments)
- Welch Allyn, Inc.: 2 (https://510kreport.com/company/welch-allyn)
- Atcor Medical: 1 (https://510kreport.com/company/atcor-medical)
- I.E.M. GmbH: 1 (https://510kreport.com/company/iem)
- Mortara Instrument, Inc.: 1 (https://510kreport.com/company/mortara-instrument)
- Nonin Medical, Inc.: 1 (https://510kreport.com/company/nonin-medical)
- Johnson & Johnson Medical, Inc.: 1 (https://510kreport.com/company/johnson-johnson-medical)

## Firms that cite its devices most
- Skanray Technologies Private Limited: 2 (https://510kreport.com/company/skanray-technologies-private)
- Seca Corp.: 1 (https://510kreport.com/company/seca)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)
- Mediaid, Inc.: 1 (https://510kreport.com/company/mediaid)
- Schiller AG: 1 (https://510kreport.com/company/schiller)
- Shenzhen Hingmed Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-hingmed-medical-instrument)

## Its most-cited devices
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System (2006), cited by 4
- K060820: Cycle BP Monitor and Pulse Oximeter, Model 1060 (2006), cited by 2
- K151520: Oscar 2 (2016), cited by 2
- K160439: SunTech CT40 Spot-check Vital Signs Device (2016), cited by 1
- K070750: 247 BP Device (2007), cited by 1

## Recent decisions
- K160439: SunTech CT40 Spot-check Vital Signs Device (Jul 6, 2016)
- K151520: Oscar 2 (Feb 19, 2016)
- K122401: Tango M2 Blood Pressure Monitor (Nov 2, 2012)
- K080854: Disposable Blood Pressure Cuff, Model DC100 (Oct 20, 2008)
- K070750: 247 BP Device (May 2, 2007)
- K060820: Cycle BP Monitor and Pulse Oximeter, Model 1060 (Jun 7, 2006)
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System (Jan 5, 2006)
- K051904: All Purpose Cuff, Model 222APC (Sep 9, 2005)

Source page: https://510kreport.com/company/suntech-medical