510(k) · Cleared
ClearedTelemedcare Health Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemedcare Pty, Ltd. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 3, 2011 as substantially equivalent to K080798 (Intel Corp., 2008) and 5 other predicates after a 219-day review. Its family tree reaches back 12 generations to 1987. 1 later device descends from it.
- Decided
- Aug 3, 2011
- Review
- 219 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K864318 (1987). 62 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations between
- 3 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- This deviceK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK122333 Mobilecare MonitorAframe Digital, Inc. · 2012
Show all 12 generations
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 10 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 9 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 8 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 7 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 6 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 5 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 4 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 3 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- This deviceK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K122333Mobilecare MonitorAframe Digital, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −11 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −10 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −9 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −8 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −7 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −6 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −5 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −4 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −3 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −2 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −1 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| 0 (this device) | K103796 | Telemedcare Health Monitor | Telemedcare Pty, Ltd. | 2011 | — |
| +1 | K122333 | Mobilecare Monitor | Aframe Digital, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K080798 | Intel Health Guide, Model: PHS6000Summary page 1…Radioftequency (21 CER 870.29 10, Product Code DRO) 5. Predicate Device(s) 5.1. Intel Health Guide PHS6000, Remote Patient Monitoring System K080798 5.2. Philips Medical Systems M3 81OA TeleMonitoring System K023 749 5.3. Bosch Health Buddy… | 2008 |
| * | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Summary page 1…dicate Device(s) 5.1. Intel Health Guide PHS6000, Remote Patient Monitoring System K080798 5.2. Philips Medical Systems M3 81OA TeleMonitoring System K023 749 5.3. Bosch Health Buddy K063 612 5.4. Tunstall Mytelemedic Plus… | 2002 |
| * | K063612 | Modification to Health Buddy ApplianceSummary page 1…K080798 5.2. Philips Medical Systems M3 81OA TeleMonitoring System K023 749 5.3. Bosch Health Buddy K063 612 5.4. Tunstall Mytelemedic Plus K090886 5.5. Carematix Wellness System… | 2006 |
| * | K090886 | RTX 3371Summary page 1…K023 749 5.3. Bosch Health Buddy K063 612 5.4. Tunstall Mytelemedic Plus K090886 5.5. Carematix Wellness System K073038 & K100508 6. Device Description The TeleMedCare Heal… | 2009 |
| * | K073038 | Carematix Wellness System, Model CWS-5000.1-BSummary page 1…K063 612 5.4. Tunstall Mytelemedic Plus K090886 5.5. Carematix Wellness System K073038 & K100508 6. Device Description The TeleMedCare Health Monitor is designed to be used in the home or community setting to enabl… | 2008 |
| * | K100508 | Carematix Wellness System, Model CWS-5000.1-BSummary page 1…K063 612 5.4. Tunstall Mytelemedic Plus K090886 5.5. Carematix Wellness System K073038 & K100508 6. Device Description The TeleMedCare Health Monitor is designed to be used in the home or community setting to enable remote c… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122333 | Mobilecare Monitor | 2012 | 0 |
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 24 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 62 ancestors have a recall of any class.
- Of its descendants, K122333 (Aframe Digital, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K080798.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The TMC Health Monitor is intended to facilitate monitoring and transmission to a remote server of certain physiological parameters relevant to the remote management of health status and chronic disease conditions.
The TMC Health Monitor is a system that provides:
Monitoring and display of vital signs/health parameters.
Management and scheduling of clinical measurements and questionnaires.
A web connection to patient health information.
Reporting to clinicians and allied health workers.
The device has been designed to provide the user with information to assist with an appropriate treatment program or further investigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103796: Telemedcare Health Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103796
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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