TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER - Manual Digital Lcd Sphygmomanometer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K092893 ↗

FDA Product Code

DXN

Models / Variants

A730

Manual Digital Lcd Sphygmomanometer

Model A830 Series

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Tytan Professional /Economy Series Sphygmomanometer, No 710/No 700

  Class II

  FDA 510(k) K033025 Active Cleared 10 Dec 2003

• Tytan Blood Pressure Cuff

  Class II

  FDA 510(k) K062238 Active Cleared 21 Sep 2006

• Tytan Electronic Stethoscopes (Model #600)

  Class II

  FDA 510(k) K023637 Active Cleared 26 Feb 2003

• What are the Tytan A730 and A830 Sphygmomanometers used for?

  These devices are noninvasive blood pressure measurement systems intended to measure systolic and diastolic blood pressures in hospital or professional environments using an inflatable cuff wrapped around the upper arm.

• How are the Tytan Sphygmomanometers supplied and what is their intended use?

  The devices are supplied for use in professional settings and are intended for single-patient use in clinical environments. They are classified as Class II medical devices.

• What regulatory clearance do these Tytan Sphygmomanometers have?

  The devices have received FDA 510(k) clearance with K number K092893, which means they are substantially equivalent to other legally marketed devices in the same product code category DXN.

• Are there different models available in the Tytan Sphygmomanometer series?

  Yes, the series includes the Automatic Aneroid Sphygmomanometer Model A730 and the Manual Digital LCD Sphygmomanometer Model A830, both designed for professional blood pressure measurement.