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 Dec 18, 2003 after a 24-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 7 later devices descend from it.
- Decided
- Dec 18, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
7 later devices descend from it, 1 citing it directly.
- This deviceK033672 Modification to Unity Network IDGe Medical Systems Information Technologies · 2003
- Descendant · cites it directly · 6 of its ownK040559 Modification to Unity Network IDGe Medical Systems Information Technologies · 2004
- Descendant · 2 generations on · 5 of its ownK051518 Unity Network IDGe Medical Systems Information Technologies · 2005
- Descendant · 3 generations on · 4 of its ownK071982 Modification to: Unity Network IDGe Medical Systems Information Technologies · 2007
- Descendant · 4 generations on · 3 of its ownK103432 Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010
- Descendant · 5 generations on · 2 of its ownK142840 Unity Network IDGE Healthcare · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040559Modification to Unity Network IDGe Medical Systems Information Technologies · 2004 · cites it directly6descendants
- K051518Unity Network IDGe Medical Systems Information Technologies · 2005 · 2 generations on5descendants
- K071982Modification to: Unity Network IDGe Medical Systems Information Technologies · 2007 · 3 generations on4descendants
- K103432Unity Network IDGe Medical Systems Information Technologies, Inc. · 2010 · 4 generations on3descendants
- K142840Unity Network IDGE Healthcare · 2015 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033672 | Modification to Unity Network ID | Ge Medical Systems Information Technologies | 2003 | — |
| +1 | K040559 | Modification to Unity Network ID | Ge Medical Systems Information Technologies | 2004 | — |
| +2 | K051518 | Unity Network ID | Ge Medical Systems Information Technologies | 2005 | — |
| +3 | K071982 | Modification to: Unity Network ID | Ge Medical Systems Information Technologies | 2007 | — |
| +4 | K103432 | Unity Network ID | Ge Medical Systems Information Technologies, Inc. | 2010 | — |
| +5 | K142840 | Unity Network ID | GE Healthcare | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K021524 | FDA’s K021524 is Light Cure Dental Dam Our reading of the summary gave K021524, FDA’s number for Light Cure Dental Dam (Prime Dental Manufacturing, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Unity Network ID”. Kept off the family tree. Summary page 1…, Patient Classification Name: 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) Predicate Device: K021524 Unity Network ID Devce escipton:The Unity Network ID system communicates patient data from source… | 2002 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040559 | Modification to Unity Network ID | 2004 | 6 |
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?
- Of its descendants, K040559 (Ge Medical Systems Information Technologies, 2004) has gone furthest, with 6 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.
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/K033672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033672: 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/K033672
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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