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TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER - Model A830 Series

by Tytan Medical Corp.

510(k) K092893

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092893 Date14 Jan 2010ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Models / Variants
Model A830 Series
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Other devices from Tytan Medical Corp.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.