510(k) · Cleared
Recalled · Class II · 2014Viewpoint Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Oct 10, 2003 as substantially equivalent to K021681 (Welch Allyn Protocol, Inc., 2002) and 2 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 10, 2003
- Review
- 126 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K903702 (1990). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK903702 Model 90421 Flexport InterfaceSpacelabs, Inc. · 1990 · Recalled
- 2 generations backK962473 (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation · 1997
- 1 generation backK020524 Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- This deviceK031760 Viewpoint Telemetry SystemDatascope Corp. · 2003
- Descendant · cites it directly · 1 of its ownK142601 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903702 | Model 90421 Flexport Interface | Spacelabs, Inc. | 1990 | 1 |
| −2 | 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 |
| 0 (this device) | K031760 | Viewpoint Telemetry System | Datascope Corp. | 2003 | — |
| +1 | K142601 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co. | 2014 | 1 |
| +2 | 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 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142601 | Panorama Patient Monitoring Network | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2014 | Class II | Z-1156-2014 | Software design | Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event… |
| Apr 10, 2009 | Not classified | Z-1401-2009 | Software design | Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in… |
| Dec 7, 2005 | Not classified | Z-0437-06 | Other | Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off. |
| Aug 19, 2005 | Not classified | Z-1567-05 | Other | The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse. |
| Jun 16, 2005 | Not classified | Z-1104-05 | Other | Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K142601 (Shenzhen Mindray Bio-Medical Electronics Co., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K021681.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Indications for use for the Viewpoint Central Monitoring System include: Viewing real time patient clinical and demographic data Graphical and numeric trending of clinical data Storing and printing of clinical and demographic data Setting independent alarm limits for data sent by the bedside monitor. The clinical data displayed by the Viewpoint Central Monitoring System is obtained from one or more Datascope compatible physiological monitors and…
Read the full statement (268 words)
The Indications for use for the Viewpoint Central Monitoring System include:
Viewing real time patient clinical and demographic data
Graphical and numeric trending of clinical data
Storing and printing of clinical and demographic data
Setting independent alarm limits for data sent by the bedside monitor.
The clinical data displayed by the Viewpoint Central Monitoring System is obtained from one or more Datascope compatible physiological monitors and includes: ECG waveforms, Invasive and Non-Invasive Blood Pressure, Blood Oxygenation (Sp02), Heart Rate, Respiration Rate, Temperature, C 0 2 inspired and end-tidal, Ventricular Arrythmia analysis and ST Segment analysis.
The Viewpoint Central Monitoring System is intended for use in a fixed location, in the health care facility setting, as a central viewing station. The Viewpoint Central Monitoring System is not intended to be directly connected to the patient at any time, or installed in a patient's vicinity.
The Viewpoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The Viewpoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.
The physiological parameters monitored include ECG, Heart Rate from ECG, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the Viewpoint Server for ECG processing via Ethernet. This information can be displayed, trended, stored, and printed at the Viewpoint Central Station.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031760: Viewpoint Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031760
Report an extraction error
Are you the manufacturer?
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