510(k) Report

510(k) · Cleared

Cleared

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream

K153719510(k) TraditionalCleared Jun 3, 2016158-day reviewClass II21 CFR 870.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Honeywell Hommed, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Jun 3, 2016 as substantially equivalent to K072272 (Honeywell Hommed, LLC, 2007) after a 158-day review. Its family tree reaches back 2 generations to 2006.

Decided
Jun 3, 2016
Review
158 days
Class
Class II
Product code
DRG
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K053453 (2006). No later device cites it as a predicate yet.

K053453 · Hommed Central Station, Version 3.5 · Honeywell Hommed, LLC · 2006K072272 · Honeywell Hommed Central Station 4.0 · Honeywell Hommed, LLC · 20072006200820102012201420162018
K072272 · Honeywell Hommed Central Station 4.0 · Honeywell Hommed, LLC · 2007K053453 · Hommed Central Station, Version 3.5 · Honeywell Hommed, LLC · 20060
  1. Root · 2 generations backK053453 Hommed Central Station, Version 3.5Honeywell Hommed, LLC · 2006
  2. 1 generation backK072272 Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC · 2007
  3. This deviceK153719 LifeStream Management System, LifeStream Management Suite…Honeywell Hommed, LLC · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K053453Hommed Central Station, Version 3.5Honeywell Hommed, LLC2006—
−1K072272Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC2007—
0 (this device)K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient…Honeywell Hommed, LLC2016—
FIG. 1 — Lineage of K153719, 2006–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DRG device

  1. #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K072272Honeywell Hommed Central Station 4.0
Summary page 5
…tal 870.2340 Cardiovascular DPS Electrocardiograph II Predicate Device(s): Central Station, Version 4.0, K072272, branded as the LifeStream™ 4.0. Predicate Classification Information: Regulation Review Panel Product…
Honeywell Hommed, LLC2007—

Also cleared against K072272: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 8.7 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K072272.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

What is it indicated for?

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface. LifeStream software’s intended use is to retrospectively receive, display and store monitored vital signs parameters and related…

Read the full statement (126 words)

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software’s intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts and system alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

Indications for use as stated in the FDA summary.

Also cleared against K072272

1 other device cites the same predicate.

  • K120320Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012

More from Honeywell Hommed, LLC

7 FDA decisions under this applicant name. See the company

  • K112858Genesis Touch SystemHoneywell Hommed, LLC · 2012
  • K101242Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
  • K072272Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC · 2007
  • K061087Genesis Otc MonitorHoneywell Hommed, LLC · 2006
  • K061088Sentry Otc MonitorHoneywell Hommed, LLC · 2006

Recent decisions in DRG

The DRG category page

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https://510kreport.com/device/K153719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153719: LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153719

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026