Suntech Medical, Inc.
Morrisville, NC, US
SUNTECH MEDICAL, INC. appears in FDA device records in Morrisville, NC. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Suntech Medical, Inc. between 2005 and 2016. The busiest year on record is 2006, with 2. The most recent is 2016, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2016 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160439 | SunTech CT40 Spot-check Vital Signs Device | DXN | Substantially Equivalent | |
| K151520 | Oscar 2 | DXN | Substantially Equivalent | |
| K122401 | TANGO M2 BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K080854 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 | DXQ | Substantially Equivalent | |
| K070750 | 247 BP DEVICE | DXN | Substantially Equivalent | |
| K060820 | CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 | DXN | Substantially Equivalent | |
| K053209 | TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM | DXN | Substantially Equivalent | |
| K051904 | ALL PURPOSE CUFF, MODEL 222APC | DXQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1036863 | 1036863 | SUNTECH MEDICAL, INC. | 5827 S. Miami Boulevard, MORRISVILLE, NC 27560 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2429-2020 | 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. | Class II | Terminated | |
| Z-0810-2020 | 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. | Class II | Terminated | |
| Z-2277-2019 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain