510(k) · Cleared
ClearedLifePath Remote Patient Monitoring Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elastic Care Incorporated · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Feb 3, 2022 as substantially equivalent to K181248 (Comarch Healthcare SA, 2018) after a 234-day review. Its family tree reaches back 18 generations to 1987. 1 later device descends from it.
- Decided
- Feb 3, 2022
- Review
- 234 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K864318 (1987). 74 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 14 generations between
- 3 generations backK122285 Tablet CommanderCardiocom, LLC · 2012
- 2 generations backK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- 1 generation backK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- This deviceK211822 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 18 generations
- Root · 18 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 17 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 16 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 15 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 14 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 13 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 12 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 11 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 10 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 9 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 8 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 7 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 6 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 5 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 4 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 3 generations backK122285 Tablet CommanderCardiocom, LLC · 2012
- 2 generations backK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- 1 generation backK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- This deviceK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
Most influential descendants
Showing 1 of 1 · See all- K252440EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −17 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −16 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −15 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −14 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −13 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −12 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −11 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −10 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −9 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −8 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −7 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −6 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −5 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −4 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| −3 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| −2 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| −1 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K181248 | Comarch e-Care PlatformSummary page 5…LifePath Remote Patient Monitoring Platform 4 LEGALLY MARKETED PREDICATE DEVICE(S) Predicate Device: Comarch e-Care Platform, K181248 5 DEVICE DESCRIPTION The LifePath Remote Patient Monitoring Platform (the “LifePath RPM Platform”) is a software applicat… | 2018 |
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 |
|---|---|---|---|
| K252440 | EasyTeleMed (2.0.2) | 2025 | 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 35 years and passes through 13 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 74 ancestors have a recall of any class.
- Of its descendants, K252440 (Ingeniars S.R.L., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181248.
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. 2022, 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 LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcare-related environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath…
Read the full statement (249 words)
The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcare-related environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices.
The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinicians using a Clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient; notifications are sent to the clinician for threshold breaches.
The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data.
The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention. It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211822: LifePath Remote Patient Monitoring Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211822
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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