510(k) · Cleared
ClearedEasyTeleMed (2.0.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingeniars S.R.L. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 2, 2025 as substantially equivalent to K211822 (Elastic Care Incorporated, 2022) and 3 other predicates after a 59-day review. Its family tree reaches back 19 generations to 1987.
- Decided
- Oct 2, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K864318 (1987). 102 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 19 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 15 generations between
- 3 generations backK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- 2 generations backK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- 1 generation backK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- This deviceK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
Show all 19 generations
- Root · 19 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 18 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 17 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 16 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 15 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 14 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 13 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 12 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 11 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 10 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 9 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 8 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 7 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 6 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 5 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 4 generations backK122285 Tablet CommanderCardiocom, LLC · 2012
- 3 generations backK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- 2 generations backK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- 1 generation backK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- This deviceK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −18 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −17 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −16 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −15 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −14 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −13 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −12 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −11 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −10 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −9 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −8 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −7 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −6 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −5 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| −4 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| −3 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| −2 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| −1 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| 0 (this device) | 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 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K211822 | LifePath Remote Patient Monitoring PlatformSummary page 5…870.2910 Product Code(s) DRG I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211822 LifePath Remote Patient Monitoring Platform DRG K181248 Comarch e-Care Platform DRG K211365 Alio Medical RMS DRG, FLL, DG K152139… | 2022 |
| * | K181248 | Comarch e-Care PlatformSummary page 5…ate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211822 LifePath Remote Patient Monitoring Platform DRG K181248 Comarch e-Care Platform DRG K211365 Alio Medical RMS DRG, FLL, DG K152139 Vital Connect Platform DRG, DS, wi Device Description S… | 2018 |
| * | K211365 | Alio Medical Remote Monitoring SystemSummary page 5…icate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211822 LifePath Remote Patient Monitoring Platform DRG K181248 Comarch e-Care Platform DRG K211365 Alio Medical RMS DRG, FLL, DG K152139 Vital Connect Platform DRG, DS, wi Device Description Summary 21 CFR 807.92(a)(4) EasyTele… | 2022 |
| * | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatchSummary page 5…Predicate is listed first) Product Code K211822 LifePath Remote Patient Monitoring Platform DRG K181248 Comarch e-Care Platform DRG K211365 Alio Medical RMS DRG, FLL, DG K152139 Vital Connect Platform DRG, DS, wi Device Description Summary 21 CFR 807.92(a)(4) EasyTeleMed is a flexible and highly configura… | 2015 |
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 38 years and passes through 14 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 102 ancestors have a recall of any class.
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. 2025, 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?
EasyTeleMed mobile applications (Home and Professional) connect with compatible physiological measurement devices intended to be used at home or healthcare-related environments to collect physiological parameters measurements and securely transmit them unaltered to the EasyTeleMed EMR Plus. The physiological parameters that can be acquired are: • Blood pressure (systolic/diastolic) • Heart rate (from ECG or auscultation) • Pulse rate (form finger or arm)…
Read the full statement (305 words)
EasyTeleMed mobile applications (Home and Professional) connect with compatible physiological measurement devices intended to be used at home or healthcare-related environments to collect physiological parameters measurements and securely transmit them unaltered to the EasyTeleMed EMR Plus. The physiological parameters that can be acquired are:
• Blood pressure (systolic/diastolic)
• Heart rate (from ECG or auscultation)
• Pulse rate (form finger or arm)
• Body weight
•ECG
• Blood glucose
• Pulse oximetry
• Spirometry
• Body temperature
• Respiratory rate
• Cardiac auscultation
• Pulmonary auscultation
EasyTeleMed serves as Software as a Medical Device and can be used only with specific FDA cleared or approved third-party measurement devices.
EasyTeleMed securely stores the collected information and makes it available for viewing by remotely located clinicians using EasyTeleMed EMR Plus, accessible via a web browser. The clinician can analyze the data, prescribe medications, set up a care plan or contact the patient if needed (via message or video calls). Clinicians can set rules (activities and thresholds) individually for each patient and for any rule breach, notification is sent to the clinician, if desired.
EasyTeleMed does not interpret, make diagnoses nor serve as a substitute for medical care. It is not intended to provide real-time data.
EasyTeleMed is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended to use on acutely or critically ill patients or those requiring time-critical or emergency intervention. EasyTeleMed is not intended for use in settings and on patients where the nature of changes in vital parameters is such that they could create an immediate danger to the patient.
EasyTeleMed is intended for patients who are willing and capable of managing its use or can be assisted by a caregiver. Clinical judgement and experience by a clinician 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/K252440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252440: EasyTeleMed (2.0.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252440
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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