Data / Medical devices / United States / Suntech Medical, Inc.
Suntech Medical, Inc.: FDA-registered device maker in Morrisville, NC, United States, 5 510(k) clearances
Suntech Medical, Inc. is registered with the FDA (registration 1036863) in Morrisville, NC, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 6, 2016. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1036863
- Address
- 5827 S. Miami Boulevard Suite 100, Morrisville, NC, United States, 27560
- Owner or operator
- SUNTECH MEDICAL, INC. (1036863)
- Roles
- Manufacturer
- First device listed
- December 7, 2006
- Registered through
- 2026
- Brand names listed
- ALL PURPOSE CUFF, CT40 Vital Signs, Disposable Cuff, Oscar 2, Model 250, SunTech Oscar 2, 24-HR ABPM, Tango M2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2016 | K160439 | SunTech CT40 Spot-check Vital Signs Device | DXN | Substantially Equivalent | Suntech Medical | accessdata.fda.gov |
| February 19, 2016 | K151520 | Oscar 2 | DXN | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| November 2, 2012 | K122401 | TANGO M2 BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| October 20, 2008 | K080854 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 | DXQ | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| September 9, 2005 | K051904 | ALL PURPOSE CUFF, MODEL 222APC | DXQ | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2020 | 85515 | Class II | Terminated | Oscar 2, Model 250 System | The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. | accessdata.fda.gov |
| December 11, 2019 | 84531 | Class II | Terminated | Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10). | The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product. | accessdata.fda.gov |
| June 3, 2019 | 83070 | Class II | Terminated | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 | Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Blood Pressure Cuff
- All makers of Oximeter
- All makers of Continuous Measurement Thermometer
Updated July 6, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.