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Hypertension Risk Detector

by Pearce Clinical Laboratories, Inc.

510(k) K871482

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 NumberK871482 Date5 Jun 1987ClearedStatusActive

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  • Withdrawn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
Hypertension Risk Detector(Tm)
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, 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 Hypertension Risk Detector is a cardiovascular device designed for the assessment of hypertension risk. It is classified under product code DXN and has been determined to be substantially equivalent to a predicate device.

The device received traditional 510(k) clearance from the FDA on June 5, 1987, under K871482. It is manufactured by Pearce Clinical Laboratories, Inc. and is intended for use in clinical settings as a cardiovascular risk assessment tool.

Other devices from Pearce Clinical Laboratories, Inc.

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 is the Hypertension Risk Detector used for?

    The Hypertension Risk Detector is a cardiovascular device designed for the assessment of hypertension risk, intended for use in clinical settings as a risk assessment tool to evaluate patient risk for hypertension.

  • How was the Hypertension Risk Detector cleared for market?

    The device received traditional 510(k) clearance from the FDA on June 5, 1987, under submission K871482, based on a determination of substantial equivalence to a predicate device.

  • Who manufactures the Hypertension Risk Detector and where are they located?

    The Hypertension Risk Detector is manufactured by Pearce Clinical Laboratories, Inc., located at 805 # San Jacinto, Conroe, TX 77301, United States.