510(k) · Cleared
Recalled · 2004Patientnet Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · MSX System, Network And Communication, Physiological Monitors
Cleared on Mar 20, 2002 as substantially equivalent to K962473 (Data Critical Corporation, 1997) after a 29-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 20, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903702 (1990). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK903702 Model 90421 Flexport InterfaceSpacelabs, Inc. · 1990 · Recalled
- 1 generation backK962473 (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation · 1997
- This deviceK020524 Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 2 of its ownK031760 Viewpoint Telemetry SystemDatascope Corp. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK142601 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K031760Viewpoint Telemetry SystemDatascope Corp. · 2003 · cites it directly2descendants
- K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · 2 generations on1descendant
- K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903702 | Model 90421 Flexport Interface | Spacelabs, Inc. | 1990 | 1 |
| −1 | K962473 | (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory… | Data Critical Corporation | 1997 | — |
| 0 (this device) | K020524 | Patientnet Monitoring System | General Electric Medical Systems Information Techn | 2002 | — |
| +1 | K031760 | Viewpoint Telemetry System | Datascope Corp. | 2003 | 5 |
| +2 | K142601 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co. | 2014 | 1 |
| +3 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K962473 | (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…Summary page 1…lassification Name: System, Network and Communication, Physiological Monitors Device Classification: Class Il Predicate Device(s): VitalCom Networked Monitoring System K962473 Device Description: The modified PatientNet™ Monitoring System performs patient monitoring using PatientNet™ ambulatory radio t… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031760 | Viewpoint Telemetry System | 2003 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2004 | Not classified | Z-0727-04 | Other | Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K031760 (Datascope Corp., 2003) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K962473.
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?
Monitoring of Recognized Conditions: -An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators. -Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or ventilators operate. -Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate…
Read the full statement (113 words)
Monitoring of Recognized Conditions:
-An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators.
-Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or 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 ventilators is transferred via an RF transmitter to the Central Monitoring Station.
Target Population:
Those patients who are connected through PatientNet™ Monitoring System via ambulatory ECG transmitters, bedside monitors, or ventilators.
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/K020524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020524: Patientnet Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020524
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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