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Healthteam Digital Blood Pressure Kit 8115

by Healthteam

510(k) K852653

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 NumberK852653 Date30 Dec 1985ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.1130
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 Healthteam Digital Blood Pressure Kit 8115 is a digital blood pressure monitoring device designed for measuring systolic and diastolic blood pressure and pulse rate. It falls under the category of automated blood pressure cuffs, intended for non-invasive assessment of cardiovascular parameters in clinical or home settings.

This device is supplied as a reusable kit, including an upper arm cuff and a digital display unit powered by batteries. It was granted FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent to a predicate device, and is intended for use in regulated medical environments. The model number 8115 is explicitly referenced in the submitted regulatory documentation.

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