510(k) · Cleared
ClearedDyna-Vision Telemonitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techmedic Development International B.V. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 29, 2016 as substantially equivalent to K141167 (Vitalconnect, Inc., 2014) and 4 other predicates after a 204-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Apr 29, 2016
- Review
- 204 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K962603 (1997). 33 ancestors in all, the oldest K891104 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 2 generations backK113054 EquivitalHidalgo Limited · 2012
- 1 generation backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- This deviceK152973 Dyna-Vision Telemonitoring SystemTechmedic Development International B.V. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −2 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −1 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| 0 (this device) | K152973 | Dyna-Vision Telemonitoring System | Techmedic Development International B.V. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 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? (5)
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 |
|---|---|---|---|
| * | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Summary page 4…nic, clinical, 880.2910 (FLL); and Oximeter, 870.2700 (DQA) Classification Panel: Cardiology Predicate Devices: Vitalconnect platform, K 141167 TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947 Model 7500 Digital… | 2014 |
| * | K092947 | Telesentry, Model TS01Summary page 4…assification Panel: Cardiology Predicate Devices: Vitalconnect platform, K 141167 TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947 Model 7500 Digital Pulse Oximeter, K080255 Disposable Temperature Probes, K070339… | 2010 |
| * | K080255 | Nonin Medical, Inc., Model 7500 Digital Pulse OximeterSummary page 4…nect platform, K 141167 TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947 Model 7500 Digital Pulse Oximeter, K080255 Disposable Temperature Probes, K070339 Propaq CS, K012451 Device Description:… | 2008 |
| * | K070339 | Disposable Temperature Probes/Sensors and Instrument CablesSummary page 4…less Ambulatory ECO Arrhythmia Monitor, K092947 Model 7500 Digital Pulse Oximeter, K080255 Disposable Temperature Probes, K070339 Propaq CS, K012451 Device Description: The Dyna-Vision system is a wireless multi-parameter data col… | 2007 |
| * | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Summary page 4…2947 Model 7500 Digital Pulse Oximeter, K080255 Disposable Temperature Probes, K070339 Propaq CS, K012451 Device Description: The Dyna-Vision system is a wireless multi-parameter data collection systems tha… | 2001 |
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 19 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 33 ancestors have a recall of any class.
- 4 other devices also cite its predicate K141167.
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. 2016, this device’s year, is highlighted.
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 Dyna-Vision Telemonitoring System is a wireless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG). Heart Rate. Heart Rate variability (R-R interval). Peripheral capillary Oxygen saturation (SpO2). Skin Temperature and respiration effort. Data is transmitted…
Read the full statement (146 words)
The Dyna-Vision Telemonitoring System is a wireless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG). Heart Rate. Heart Rate variability (R-R interval). Peripheral capillary Oxygen saturation (SpO2). Skin Temperature and respiration effort.
Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment.
The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
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/K152973 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152973: Dyna-Vision Telemonitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152973
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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