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Mednova Blood Pressure Cuff

by Mednova Corp.

510(k) K854813

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 NumberK854813 Date20 Jun 1986ClearedStatusActive

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  • Withdrawn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
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Mednova Blood Pressure Cuff is a Class II medical device designed for measuring blood pressure in patients. It features an inflatable bladder within an inelastic wrap, conforming to the FDA’s classification under Blood Pressure Cuff (Regulation 870.1120).

This cuff is intended for single-use or reusable applications in clinical settings, such as hospitals, physician offices, or home monitoring, depending on manufacturer guidelines. It adheres to FDA 510(k) clearance (K854813, Product Code DXQ) under the Cardiovascular advisory committee, with a decision of Substantially Equivalent (SESE) dated June 20, 1986. No third-party review was required.

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