510(k) · Cleared
ClearedUnity Network ID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 12, 2017 as substantially equivalent to K142840 (GE Healthcare, 2015) after a 109-day review. Its family tree reaches back 6 generations to 2003. 1 later device descends from it.
- Decided
- May 12, 2017
- Review
- 109 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K033672 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK033672 Modification to Unity Network IDGe Medical Systems Information Technologies · 2003
- 5 generations backK040559 Modification to Unity Network IDGe Medical Systems Information Technologies · 2004
- 4 generations backK051518 Unity Network IDGe Medical Systems Information Technologies · 2005
- 3 generations backK071982 Modification to: Unity Network IDGe Medical Systems Information Technologies · 2007
- 2 generations backK103432 Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010
- 1 generation backK142840 Unity Network IDGE Healthcare · 2015
- This deviceK170199 Unity Network IDGE Healthcare · 2017
- Descendant · cites it directly · 0 of its ownK183116 Unity Network IDGE Healthcare · 2018
Most influential descendants
Showing 1 of 1 · See all- K183116Unity Network IDGE Healthcare · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K033672 | Modification to Unity Network ID | Ge Medical Systems Information Technologies | 2003 | — |
| −5 | K040559 | Modification to Unity Network ID | Ge Medical Systems Information Technologies | 2004 | — |
| −4 | K051518 | Unity Network ID | Ge Medical Systems Information Technologies | 2005 | — |
| −3 | K071982 | Modification to: Unity Network ID | Ge Medical Systems Information Technologies | 2007 | — |
| −2 | K103432 | Unity Network ID | Ge Medical Systems Information Technologies, Inc. | 2010 | — |
| −1 | K142840 | Unity Network ID | GE Healthcare | 2015 | — |
| 0 (this device) | K170199 | Unity Network ID | GE Healthcare | 2017 | — |
| +1 | K183116 | Unity Network ID | GE Healthcare | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142840 | Unity Network IDSummary page 4…CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms Regulatory Class: II Product Code: MWI III. PREDICATE DEVICE Unity Network ID v7 K142840 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVIC… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183116 | Unity Network ID | 2018 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K183116 (GE Healthcare, 2018) has gone furthest, with 0 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. 2017, 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/K170199 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170199: 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/K170199
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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