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Sensocor Diasys

by Sensormedix, Inc.

510(k) K881771

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 NumberK881771 Date12 Jan 1989ClearedStatusActive

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  • Withdrawn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)

Full name
Sensocor(Tm) Diasys
510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Sensocor Diasys is a cardiac monitoring device designed for continuous, real-time assessment of cardiac function, specifically targeting hemodynamic parameters such as blood pressure and cardiac output. Classified under product code DXN, it is intended for use in clinical settings to provide critical physiological data for patient management. Its primary function aligns with the Cardiovascular advisory committee classification, supporting diagnostic and therapeutic decision-making in acute care environments.

Supplied as a reusable medical device, the Sensocor Diasys is regulated under FDA 510(k) clearance (K881771) with a decision date of January 12, 1989. It is intended for use in hospital or intensive care settings, where its hemodynamic monitoring capabilities are integrated into patient care protocols. The device’s specifications and regulatory pathway reflect its role in cardiovascular diagnostics, though no additional sterility, MRI safety, or single-use details are provided in the available data.

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