# Suntech Medical Instruments, Inc.

- Location (FDA's records): Raleigh, NC
- FDA decisions: 5 (1992–2001): 5 510(k) clearances
- Product codes: DXN (5)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 13 (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 that cite its devices most
- Suntech Medical, Inc.: 3 (https://510kreport.com/company/suntech-medical)
- Schiller AG: 2 (https://510kreport.com/company/schiller)
- Canamet Canadian Natl Medical Technologies, Inc.: 1 (https://510kreport.com/company/canamet-canadian-natl-medical-technologies)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Biotrac, Inc.: 1 (https://510kreport.com/company/biotrac)
- Qrs Diagnostic, LLC: 1 (https://510kreport.com/company/qrs-diagnostic)
- Novacor France: 1 (https://510kreport.com/company/novacor-france)
- Vasomedical, Inc.: 1 (https://510kreport.com/company/vasomedical)

## Its most-cited devices
- K003004: Oscar 2, Model 222 (2000), cited by 7
- K913844: Accutracker DX (1992), cited by 3
- K970629: Tango Non-Invasive Blood Pressure Monitor (1998), cited by 2
- K010622: Pressure Trak, Model 222-B (2001), cited by 1

## Recent decisions
- K010622: Pressure Trak, Model 222-B (Mar 29, 2001)
- K003004: Oscar 2, Model 222 (Oct 25, 2000)
- K970629: Tango Non-Invasive Blood Pressure Monitor (Jan 2, 1998)
- K914260: 4240 Dynamic BP/Heart Rate Monitor (Sep 4, 1992)
- K913844: Accutracker DX (Jul 14, 1992)

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