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SUNTECH MEDICAL, INC.

United States·US-MF-000002189

Last updated September 17, 2026

Information

Page 22 of 22

Device	Model / Reference	Registries	Class	Status
247 Bp Device	K070750	FDA 510(k)	Class II	Active
SunTech CT40 Spot-check Vital Signs Device	K160439	FDA 510(k)	Class II	Active
Cycle Bp Monitor And Pulse Oximeter, Model 1060	K060820	FDA 510(k)	Class II	Active
Tango M2 Blood Pressure Monitor	K122401	FDA 510(k)	Class II	Active
Tango+ Automatic Blood Pressure And Oxygen Saturation Measurement System	K053209	FDA 510(k)	Class II	Active
All Purpose Cuff, Model 222apc	K051904	FDA 510(k)	Class II	Active
Disposable Blood Pressure Cuff, Model Dc100	K080854	FDA 510(k)	Class II	Active
Tango M2	99-0088-14	EUDAMEDFDA UDI	Class IIa	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 20, 2020	Z-2429-2020	—	terminated	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.
Dec 11, 2019	Z-0810-2020	—	terminated	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.
Jun 3, 2019	Z-2277-2019	—	terminated	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.