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

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

510(k) Number

K033025 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Tytan Blood Pressure Cuff

  Class II

  FDA 510(k) K062238 Active Cleared 21 Sep 2006

• Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD Sphygmomanometer, Model A830 Series

  Class II

  FDA 510(k) K092893 Active Cleared 14 Jan 2010

• Tytan Electronic Stethoscopes (Model #600)

  Class II

  FDA 510(k) K023637 Active Cleared 26 Feb 2003

• What types of settings can the Tytan Professional/Economy Series Sphygmomanometer be used in, and who can operate it?

  The Tytan Professional/Economy Series Sphygmomanometer (models No 710/No 700) is designed for use in both clinical environments like hospitals or doctor’s offices and home settings. It is intended for operation by trained clinicians or users who understand how to take accurate blood pressure readings manually.

• Is the Tytan Professional/Economy Series Sphygmomanometer reusable, and how should it be handled for repeated use?

  Yes, the Tytan Professional/Economy Series Sphygmomanometer is a reusable device. Since it is not pre-sterilized, users must ensure proper cleaning and sterilization between uses to maintain hygiene and functionality, following standard medical device guidelines for reusable equipment.

• What are the key components of the Tytan Professional/Economy Series Sphygmomanometer, and how does it work?

  The device consists of an inflatable cuff, a pressure gauge, and an inflation bulb. It works by wrapping the cuff around a patient’s arm, inflating it to occlude the artery, and then gradually deflating while monitoring pressure to determine systolic and diastolic blood pressure values.

• Are there any special storage instructions for the Tytan Professional/Economy Series Sphygmomanometer?

  While specific storage conditions aren’t detailed, the device should be stored according to standard medical device guidelines to preserve its accuracy and functionality. This typically includes keeping it in a clean, dry environment away from extreme temperatures or direct sunlight.

• What regulatory pathway was followed for FDA clearance of the Tytan Professional/Economy Series Sphygmomanometer?

  The Tytan Professional/Economy Series Sphygmomanometer (models No 710/No 700) received FDA 510(k) clearance under the Substantially Equivalent determination, reviewed by the Cardiovascular (CV) Advisory Committee. The clearance was granted via a traditional review process, with the device classified under product code DXN.