510(k) · Cleared
Cleared(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Data Critical Corporation · MSX System, Network And Communication, Physiological Monitors
Cleared on Nov 6, 1997 as substantially equivalent to K942147 (Accucore, Inc., 1995) and 2 other predicates after a 499-day review. Its family tree reaches back 1 generation to 1990. 5 later devices descend from it.
- Decided
- Nov 6, 1997
- Review
- 499 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K903702 (1990). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903702 Model 90421 Flexport InterfaceSpacelabs, Inc. · 1990 · Recalled
- This deviceK962473 (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation · 1997
- Descendant · cites it directly · 3 of its ownK020524 Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- Descendant · 2 generations on · 2 of its ownK031760 Viewpoint Telemetry SystemDatascope Corp. · 2003 · Recalled
- Descendant · 3 generations on · 1 of its ownK142601 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK980045 Centurion Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc. · 1998
Most influential descendants
Showing 5 of 5 · See all- K020524Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · cites it directly3descendants
- K031760Viewpoint Telemetry SystemDatascope Corp. · 2003 · 2 generations on2descendants
- K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · 3 generations on1descendant
- K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on0descendants
- K980045Centurion Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903702 | Model 90421 Flexport Interface | Spacelabs, Inc. | 1990 | 1 |
| 0 (this device) | K962473 | (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory… | Data Critical Corporation | 1997 | — |
| +1 | K020524 | Patientnet Monitoring System | General Electric Medical Systems Information Techn | 2002 | 1 |
| +2 | K031760 | Viewpoint Telemetry System | Datascope Corp. | 2003 | 5 |
| +3 | K142601 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co. | 2014 | 1 |
| +4 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 |
| +1 | K980045 | Centurion Central Station Arrhythmia Patient Monitoring System | Invivo Research, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K942147 | Pacific Communications Model 1100Summary page 1…ocardiographic Transmitters and Receivers, Physiological Signal, Radiofrequency Arrhythmia and ST Segment Substantially Equivalent to: VCOM Central Monitoring Station (K942147) V-PAK and V-LINK Transmitters (K942147) Arrhythmia and ST Segment (K942147) SUMMARY INTENDED USE 1.1.1. PURPOSE AND FUNCTION… | 1995 |
| * | K913038 | Spacelab Model 90845 PCMS Multidisclosure StationSummary page 7…system with the expanded intended use is substantially equivalent to the VitalCom MPC 1100 (K942147) and, for use with ventilators, Spacelabs’ PCMS Monitor, Model 90845 (K913038) with Flexport Interface (K903702). The VCOM uses a pentium based personal computer and offers a wireless intcrface (radio transm… | 1991 |
| * | K903702 | Model 90421 Flexport InterfaceSummary page 7…use is substantially equivalent to the VitalCom MPC 1100 (K942147) and, for use with ventilators, Spacelabs’ PCMS Monitor, Model 90845 (K913038) with Flexport Interface (K903702). The VCOM uses a pentium based personal computer and offers a wireless intcrface (radio transmitters and rcccivers). This techno… | 1990 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
The indications for use of the VitalCom Networked Monitoring™ system (VCOM, IRVS/RVS) are: Monitoring of Recognized Conditions An environmentally controlled clinical settings that has multiple patients using any combination of ECG leads, bedside monitors or Nellcor Puritan Bennett (NPB) 7200 series ventilators. Hospital areas that have the capability of installing hardwire paths to the VitalCom’s Central Monitoring Station (VCOM) from the rooms or areas…
Read the full statement (289 words)
The indications for use of the VitalCom Networked Monitoring™ system (VCOM, IRVS/RVS) are:
Monitoring of Recognized Conditions
An environmentally controlled clinical settings that has multiple patients using any combination of ECG leads, bedside monitors or Nellcor Puritan Bennett (NPB) 7200 series ventilators.
Hospital areas that have the capability of installing hardwire paths to the VitalCom’s Central Monitoring Station (VCOM) from the rooms or areas where bedside monitors or NPB 7200 series ventilators operate.
Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or NPB 7200 series ventilators is transferred via an RF transmitter to the Central Monitoring Station (VCOM).
The Target Population
Those patients who are connected through the VitalCom Networked Monitoring™ system via ambulatory ECG transmitters, bedside monitors or NPB 7200 series ventilators.
Important Limitations
Each VitalCom Network Monitoring™ system can monitor up to a maximum of 10 patients per Central Monitoring Station (VCOM) and 200 patients per VitalCom Networked Monitoring™ system.
- The VitalCom Central Monitoring Station (VCOM) is to be installed at the point of care locations that have the capability of installing hardwire paths to a VCOM from rooms or areas where bedside monitors or NPB 7200 series ventilators operate.
If employing wide area networking technology, the communication between the VCOM, at the point of care location, and the IRVS/RVS, at the supplementary care location, is facilitated by dedicated telephone lines and commercially available interface hardware.
The VitalCom Networked Monitoring™ system is not for use in the home.
The Central Monitoring Station (VCOM), is only used at the pomt of care location and is capable of operating independently of any IRVS/RVS connections.
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/K962473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962473: (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962473
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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