510(k) · Cleared
ClearedVectraplex CMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vectracor, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jan 30, 2015 as substantially equivalent to K022507 (Datex-Ohmeda, 2002) and 1 other predicate after a 302-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jan 30, 2015
- Review
- 302 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933143 (1994). 24 ancestors in all, the oldest K781836 (1978). No later device cites it as a predicate yet.
- Root · 5 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 4 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 3 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 2 generations backK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- 1 generation backK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
- This deviceK140852 Vectraplex CMSVectracor, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −4 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −3 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −2 | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| −1 | K080192 | Hypervisor VI Central Monitoring System (Including TMS) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 2 |
| 0 (this device) | K140852 | Vectraplex CMS | Vectracor, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K022507 | Datex-Ohmeda S/5 Network and Central '02Summary page 4…ith arrhythmia detection or alarms) MHX Class II 870.1025 3. Predicate Device Identification Datex-Ohmeda S/5 Network and Central ’02 – 510(k) K022507 Mindray North America DPM Central Station – 510(k) K080192… | 2002 |
| * | K080192 | Hypervisor VI Central Monitoring System (Including TMS)Summary page 4…dicate Device Identification Datex-Ohmeda S/5 Network and Central ’02 – 510(k) K022507 Mindray North America DPM Central Station – 510(k) K080192 9… | 2008 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K022507.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
Vectraplex® CMS is a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control The device is intended to be used by qualified medical professionals The Vectraplex CMS will…
Read the full statement (143 words)
Vectraplex® CMS is a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices
The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control
The device is intended to be used by qualified medical professionals
The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition.
The Vectraplex CMS’ intended use population consists of those patients with certain medical conditions in whom continuous cardiac monitoring is considered to be a medical necessity in the judgment of the ordering healthcare provider.
The Vectraplex CMS is intended for centralized monitoring of patients through a network in hospitals, Emergency Departments and Surgical Centers, doctor’s offices, and urgent care facilities.
Not for home use
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/K140852 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140852: Vectraplex CMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140852
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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