510(k) Report

510(k) · Cleared

Cleared

Modification to Unity Network ID

K040559510(k) SpecialCleared Jun 4, 200493-day reviewClass II21 CFR 870.2300

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

Ge Medical Systems Information Technologies · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Jun 4, 2004 as substantially equivalent to K033672 (Ge Medical Systems Information Technologies, 2003) after a 93-day review. Its family tree reaches back 1 generation to 2003. 6 later devices descend from it.

Decided
Jun 4, 2004
Review
93 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K033672 (2003). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant clearedK033672 · Modification to Unity Network ID · Ge Medical Systems Information Technologies · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K033672 · Modification to Unity Network ID · Ge Medical Systems Information Technologies · 20030+5
  1. Root · 1 generation backK033672 Modification to Unity Network IDGe Medical Systems Information Technologies · 2003
  2. This deviceK040559 Modification to Unity Network IDGe Medical Systems Information Technologies · 2004
  3. Descendant · cites it directly · 5 of its ownK051518 Unity Network IDGe Medical Systems Information Technologies · 2005
  4. Descendant · 2 generations on · 4 of its ownK071982 Modification to: Unity Network IDGe Medical Systems Information Technologies · 2007
  5. Descendant · 3 generations on · 3 of its ownK103432 Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010
  6. Descendant · 4 generations on · 2 of its ownK142840 Unity Network IDGE Healthcare · 2015
  7. Descendant · 5 generations on · 1 of its ownK170199 Unity Network IDGE Healthcare · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12010: 12015: 12017: 12018: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K051518Unity Network IDGe Medical Systems Information Technologies · 2005 · cites it directly5descendants
  • K071982Modification to: Unity Network IDGe Medical Systems Information Technologies · 2007 · 2 generations on4descendants
  • K103432Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010 · 3 generations on3descendants
  • K142840Unity Network IDGE Healthcare · 2015 · 4 generations on2descendants
  • K170199Unity Network IDGE Healthcare · 2017 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K033672Modification to Unity Network IDGe Medical Systems Information Technologies2003—
0 (this device)K040559Modification to Unity Network IDGe Medical Systems Information Technologies2004—
+1K051518Unity Network IDGe Medical Systems Information Technologies2005—
+2K071982Modification to: Unity Network IDGe Medical Systems Information Technologies2007—
+3K103432Unity Network IDGe Medical Systems Information Technologies, Inc.2010—
+4K142840Unity Network IDGE Healthcare2015—
+5K170199Unity Network IDGE Healthcare2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
201010
201510
201710
201810
FIG. 1 — Lineage of K040559, 2003–2018Source: 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 MWI? 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 MWI device

  1. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K033672Modification to Unity Network ID
Summary page 1
…ient Classification Name: 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) Predicate Device: K033672 Unity Network ID escipton:The Unity Network ID system communicates patient data from sources…
Ge Medical Systems Information Technologies2003—

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051518Unity Network IDGe Medical Systems Information Technologies20055

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?

  • Its one ancestor has no recall.
  • Of its descendants, K051518 (Ge Medical Systems Information Technologies, 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

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

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

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

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, 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
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

What is it indicated for?

The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/information systems) it is connected to.

Indications for use as stated in the FDA summary.

More from Ge Medical Systems Information…

140 FDA decisions under this applicant name. See the company

  • K120770QT Guard Plus Analysis SystemGe Medical Systems Information Technologies · 2012
  • K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
  • K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
  • K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009
  • K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 20099 recalls

Recent decisions in MWI

The MWI category page

  • K260801Sensinel Cardiopulmonary Management (CPM) SystemAnalog Devices · 2026
  • K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc. · 2026
  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026
  • K253436c-med0 alphaCosinuss GmbH · 2026

https://510kreport.com/device/K040559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040559: Modification to Unity Network ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040559

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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