510(k) · Cleared
Recalled · Class II · 2012Viterion 100 Telehealth Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viterion Telehealthcare, LLC · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 6, 2003 as substantially equivalent to K004050 (Matsushita Electric Industrial Co., Ltd., 2001) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 1987. 88 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 6, 2003
- Review
- 269 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864318 (1987). 7 ancestors in all. 88 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 1 generation backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- This deviceK030419 Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 2003
- Descendant · cites it directly · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- Descendant · 2 generations on · 45 of its ownK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- Descendant · cites it directly · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- Descendant · cites it directly · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- Descendant · cites it directly · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · cites it directly86descendants
- K050929The Hermes SystemPalaistra Systems, Inc. · 2005 · 2 generations on45descendants
- K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · cites it directly45descendants
- K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · cites it directly40descendants
- K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −1 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| 0 (this device) | K030419 | Viterion 100 Telehealth Monitor | Viterion Telehealthcare, LLC | 2003 | — |
| +1 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| +2 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| +1 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| +1 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| +1 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 12 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 13 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K004050 | Panasonic Tele-Homecare System | 2001 |
| * | K952979 | Hanc NetworkSummary page 3…I, 870.2300 Substantial Equivalence Claimed to: 1. KO04050 Panasonic Tele-Homecare System, Matsushita Electric Industrial Co., Ltd. 2. K952979 HANC Network, HealthTech Services Corp Description/Intended Use: The Viterion 100 TeleHealth Monitor is a physiological monitori… | 1996 |
What descends from it? (88)
See all 885 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040966 | Modification to Carematix Wellness System | 2004 | 86 |
| K042273 | Modification to Health Buddy with Device Connectivity | 2004 | 45 |
| K050567 | Health Buddy Appliance | 2005 | 40 |
| K060843 | Modification to Health Buddy Appliance | 2006 | 39 |
| K050951 | Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360… | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2012 | Class II | Z-0821-2013 | Software design | Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek… |
| Nov 15, 2012 | Class II | Z-0820-2013 | Software design | Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K040966 (Carematix, Inc., 2004) has gone furthest, with 86 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Viterionl 00 TeleHealth Monitor is a physiological monitoring system. The system collects, accumulates, transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and practitioner. It can record physiological information such as:
Blood PressurePulse
Blood Hemoglobin Oxygen Saturation (SpOz)
Bodyweight
Blood Glucose
Temperature
Respiratory Peak Flow
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/K030419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030419: Viterion 100 Telehealth Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030419
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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