510(k) · Cleared

Cleared

Unity Network ID

K021454510(k) TraditionalCleared Oct 1, 2002148-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

General Electric Medical Systems Information Techn · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Oct 1, 2002 as substantially equivalent to K012094 (Agilent Technologies, Inc., 2001) after a 148-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Oct 1, 2002
Review: 148 days
Class: Class II
Product code: MWI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K012094 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK012094 Modification to Device Link System, Model M2376AAgilent Technologies, Inc. · 2001
This deviceK021454 Unity Network IDGeneral Electric Medical Systems Information Techn · 2002
Descendant · cites it directly · 0 of its ownK061590 Smdie Device Interfacing SystemSiemens Medical Solutions Health Services Corporat · 2006

Most influential descendants

Showing 1 of 1 · See all

K061590Smdie Device Interfacing SystemSiemens Medical Solutions Health Services Corporat · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012094	Modification to Device Link System, Model M2376A	Agilent Technologies, Inc.	2001	—
0 (this device)	K021454	Unity Network ID	General Electric Medical Systems Information Techn	2002	—
+1	K061590	Smdie Device Interfacing System	Siemens Medical Solutions Health Services Corporat	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K021454, 2001–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K012094	Modification to Device Link System, Model M2376A	Agilent Technologies, Inc.	2001	—

Also cleared against K012094: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K061590	Smdie Device Interfacing System	Siemens Medical Solutions Health Services Corporat	2006	0

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, K061590 (Siemens Medical Solutions Health Services Corporat, 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K012094.

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

2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	42	1	3
2008	9	49	1	3
2009	6	112	2	20
2010	17	58	2	17
2011	11	78	3	16
2012	13	104	5	31
2013	20	85	3	42
2014	16	148	6	30
2015	19	127	1	31
2016	12	165	0	51
2017	13	205	2	85
2018	11	217	0	158
2019	14	255	4	169
2020	8	138	0	110
2021	9	161	0	188
2022	5	231	2	168
2023	8	250	0	179
2024	10	202	5	120
2025	4	247	0	182
2026	6	239	9	—

What is it indicated for?

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.

https://510kreport.com/device/K021454 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021454: Unity Network ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021454

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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