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LifeStream Management System

by Honeywell Hommed, LLC

510(k) K153719

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 NumberK153719 Date3 Jun 2016ClearedStatusActive

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  • Withdrawn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
LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
510(k) Number
FDA Product Code
DRG
Device Class
Class II
Regulation
21 CFR Part 870.2910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 LifeStream Management System is a prescription-based software platform for retrospective management of patient vital signs. It receives data from Honeywell HomMed monitors and third-party MDDS devices via web services or Bluetooth.

The device is supplied by Honeywell Hommed, LLC and is authorized under FDA 510K clearance with product code DRG. It is classified as Transmitters And Receivers, Physiological Signal, Radiofrequency and is intended for cardiovascular use.

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Questions

AI-generated answers, 28 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 LifeStream Management System used for?

    The LifeStream Management System is a prescription-based software platform designed for the retrospective management of patient vital signs. It receives data from Honeywell Hommed monitors and third-party MDDS devices via web services or Bluetooth.

  • How is the LifeStream Management System supplied?

    The device is supplied by Honeywell Hommed, LLC. It is a software platform that connects to various monitoring devices to collect and manage patient vital sign data.

  • What is the regulatory status of the LifeStream Management System?

    The LifeStream Management System is authorized under FDA 510K clearance with product code DRG. It is classified as Transmitters And Receivers, Physiological Signal, Radiofrequency and is intended for cardiovascular use.

  • What devices can connect to the LifeStream Management System?

    The LifeStream Management System receives data from Honeywell Hommed monitors and third-party MDDS devices via web services or Bluetooth, allowing for comprehensive vital sign data collection.