510(k) · Cleared
ClearedModification to: Unity Network ID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 21, 2007 as substantially equivalent to K051518 (Ge Medical Systems Information Technologies, 2005) after a 64-day review. Its family tree reaches back 3 generations to 2003. 4 later devices descend from it.
- Decided
- Sep 21, 2007
- Review
- 64 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K033672 (2003). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK033672 Modification to Unity Network IDGe Medical Systems Information Technologies · 2003
- 2 generations backK040559 Modification to Unity Network IDGe Medical Systems Information Technologies · 2004
- 1 generation backK051518 Unity Network IDGe Medical Systems Information Technologies · 2005
- This deviceK071982 Modification to: Unity Network IDGe Medical Systems Information Technologies · 2007
- Descendant · cites it directly · 3 of its ownK103432 Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK142840 Unity Network IDGE Healthcare · 2015
- Descendant · 3 generations on · 1 of its ownK170199 Unity Network IDGE Healthcare · 2017
- Descendant · 4 generations on · 0 of its ownK183116 Unity Network IDGE Healthcare · 2018
Most influential descendants
Showing 4 of 4 · See all- K103432Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010 · cites it directly3descendants
- K142840Unity Network IDGE Healthcare · 2015 · 2 generations on2descendants
- K170199Unity Network IDGE Healthcare · 2017 · 3 generations on1descendant
- K183116Unity Network IDGE Healthcare · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033672 | Modification to Unity Network ID | Ge Medical Systems Information Technologies | 2003 | — |
| −2 | K040559 | Modification to Unity Network ID | Ge Medical Systems Information Technologies | 2004 | — |
| −1 | K051518 | Unity Network ID | Ge Medical Systems Information Technologies | 2005 | — |
| 0 (this device) | K071982 | Modification to: Unity Network ID | Ge Medical Systems Information Technologies | 2007 | — |
| +1 | K103432 | Unity Network ID | Ge Medical Systems Information Technologies, Inc. | 2010 | — |
| +2 | K142840 | Unity Network ID | GE Healthcare | 2015 | — |
| +3 | K170199 | Unity Network ID | GE Healthcare | 2017 | — |
| +4 | K183116 | Unity Network ID | GE Healthcare | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K051518 | Unity Network IDSummary page 1…21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) Predicate Devices: K051518 Unity Network ID Device Description: The Unity Network ID system communicates patient data from sou… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103432 | Unity Network ID | 2010 | 3 |
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 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103432 (Ge Medical Systems Information Technologies, Inc., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 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?
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.
https://510kreport.com/device/K071982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071982: 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/K071982
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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