510(k) · Cleared
ClearedVector Event Grid Architecture (Vega) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvon, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 22, 2010 as substantially equivalent to K032142 (Capsule Technologie, 2003) after an 85-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 22, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000635 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
- 3 generations backK013019 DatacaptorCapsule Technologie · 2001 · Recalled
- 2 generations backK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
- 1 generation backK032142 DatacaptorCapsule Technologie · 2003 · Recalled
- This deviceK102135 Vector Event Grid Architecture (Vega) SystemNuvon, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000635 | Modification to HP M2376A Device Link System | Agilent Technologies, Inc. | 2000 | — |
| −3 | K013019 | Datacaptor | Capsule Technologie | 2001 | 2 |
| −2 | K020197 | Modification to Datacaptor | Capsule Technologie | 2002 | 2 |
| −1 | K032142 | Datacaptor | Capsule Technologie | 2003 | 2 |
| 0 (this device) | K102135 | Vector Event Grid Architecture (Vega) System | Nuvon, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K032142 | DatacaptorSummary page 5…Name/Product Code/CFR Reference ' Software, transmission and storage, patient data Product Code: NSX, MWI CRF Reference: Not classified Predicate Device Data Captor, K032142, developed by Capsule Technologie, Inc. Intended Use / Indications for Use The VEGA System is intended to be used for data colle… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K032142.
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. 2010, 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 Vector Event Grid Architecture System is intended for use in data collection from bedside and point of care biomedical devices and clinical information management systems either directly or through networks with independent bedside devices. The Vector Event Grid Architecture System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102135: Vector Event Grid Architecture (Vega) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102135
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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