510(k) · Cleared
ClearedComarch e-Care Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comarch Healthcare SA · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 22, 2018 as substantially equivalent to K103276 (Intel Corporation Digital Health Group, 2011) and 2 other predicates after a 165-day review. Its family tree reaches back 17 generations to 1987. 2 later devices descend from it.
- Decided
- Oct 22, 2018
- Review
- 165 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K864318 (1987). 73 ancestors in all, the oldest K790130 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 13 generations between
- 3 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 2 generations backK122285 Tablet CommanderCardiocom, LLC · 2012
- 1 generation backK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- This deviceK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · cites it directly · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- Descendant · cites it directly · 0 of its ownK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
Show all 17 generations
- Root · 17 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 16 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 15 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 14 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 13 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 12 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 11 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 10 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 9 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 8 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 7 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 6 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 5 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 4 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 3 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 2 generations backK122285 Tablet CommanderCardiocom, LLC · 2012
- 1 generation backK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- This deviceK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
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 |
|---|---|---|---|---|---|
| −17 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −16 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −15 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −14 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −13 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −12 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −11 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −10 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −9 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −8 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −7 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −6 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −5 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −4 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −3 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| −2 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| −1 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| 0 (this device) | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +1 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| +1 | K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025 | — |
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 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103276 | Intel Health GuideSummary page 4…Name: Remote Patient Monitoring System 3. Information for the 510(k) Cleared Device (Predicate Device): Primary Predicate: Intel® Health Guide Express, K103276 Reference Predicates: HealthInterlink Beacon, K133252 MedApps 2.0 Remote Patient Monitoring System, K124000… | 2011 |
| * | K133252 | Healthinterlink BeaconSummary page 4…510(k) Cleared Device (Predicate Device): Primary Predicate: Intel® Health Guide Express, K103276 Reference Predicates: HealthInterlink Beacon, K133252 MedApps 2.0 Remote Patient Monitoring System, K124000 4. Device Description: Comarch e-Care Platform is a softw… | 2014 |
| * | K124000 | Medapps 2.0 - Remote Patient Monitoring SystemSummary page 4…dicate: Intel® Health Guide Express, K103276 Reference Predicates: HealthInterlink Beacon, K133252 MedApps 2.0 Remote Patient Monitoring System, K124000 4. Device Description: Comarch e-Care Platform is a software intended for use in remote patient monitoring outs… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 73 ancestors have a recall of any class.
- Of its descendants, K211822 (Elastic Care Incorporated, 2022) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K103276.
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. 2018, 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 Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices. Comarch e-Care Platform displays the collected…
Read the full statement (213 words)
The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices.
Comarch e-Care Platform displays the collected measurements on the Web application and securely stores them in a database server, where the caregiver can view the results, analyze them, leave comments and contact patient if necessary. Caregivers are able to set thresholds individually for each patient. Measurement results sent to e-Care Platform from connected devices are analyzed and if result is beyond the threshold, caregiver gets the notification.
The Comarch e-Care Platform is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The Comarch e-Care Platform is contraindicated for patients requiring direct - medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
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/K181248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181248: Comarch e-Care Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181248
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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