Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD Sphygmomanometer, Model A830 Series
by Tytan Medical Corp. 510(k)
Active
510(k) K092893
Overview
The Tytan Automatic Aneroid Sphygmomanometer Model A730 and Manual Digital LCD Sphygmomanometer Model A830 Series are noninvasive blood pressure measurement systems intended to measure systolic and diastolic blood pressures in hospital or professional environments. These devices use a non-invasive technique involving an inflatable cuff wrapped around the upper arm to measure blood pressure.
The devices are supplied for use in professional settings and have received FDA 510(k) clearance with K number K092893. They are classified as Class II medical devices and are intended for single-patient use in clinical environments. No specific information regarding sterility, MRI safety, or storage conditions is provided in the device data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092893 | Date14 Jan 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tytan Medical Corp.
Questions
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.