510(k) · Cleared
ClearedMedapps 2.0 Remote Patient Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medapps, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 5, 2009 as substantially equivalent to K080798 (Intel Corp., 2008) and 2 other predicates after a 158-day review. Its family tree reaches back 12 generations to 1987. 12 later devices descend from it.
- Decided
- Jun 5, 2009
- Review
- 158 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K864318 (1987). 60 ancestors in all, the oldest K790130 (1979). 12 later devices descend from it, 7 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 deviceK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- Descendant · cites it directly · 4 of its ownK112559 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · 3 generations on · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
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 deviceK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013 · cites it directly4descendants
- K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011 · cites it directly4descendants
- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · 2 generations on3descendants
- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · 2 generations on2descendants
- K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022 · 3 generations on1descendant
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) | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +1 | K124000 | Medapps 2.0 - Remote Patient Monitoring System | Medapps Inc., Dba Alere Connect | 2013 | — |
| +1 | K112559 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2011 | — |
| +2 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +2 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +3 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
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 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K080798 | Intel Health Guide, Model: PHS6000Summary page 1…Radiofrequency (21 CFR 870.2910, Product Code DRG) A. LEGALLY MARKETED PREDICATE DEVICE Legally marketed predicate device are: K080798 Intel Health Guide PHS6000 K072698 Confidant 2.5 K062377 MedApps Remote Patient Monitoring System (… | 2008 |
| * | K072698 | Confidant 2.5Summary page 1…870.2910, Product Code DRG) A. LEGALLY MARKETED PREDICATE DEVICE Legally marketed predicate device are: K080798 Intel Health Guide PHS6000 K072698 Confidant 2.5 K062377 MedApps Remote Patient Monitoring System (D-PAL) B. DEVICE DESCRIPTION The M… | 2007 |
| * | K062377 | Medapps Remote Patient Monitoring, Model MA 100Summary page 1…LEGALLY MARKETED PREDICATE DEVICE Legally marketed predicate device are: K080798 Intel Health Guide PHS6000 K072698 Confidant 2.5 K062377 MedApps Remote Patient Monitoring System (D-PAL) B. DEVICE DESCRIPTION The MedApps 2.0 - Remote Patient Monito… | 2007 |
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124000 | Medapps 2.0 - Remote Patient Monitoring System | 2013 | 4 |
| K112559 | Medapps 2.0 Remote Patient Monitoring System | 2011 | 4 |
| K110316 | Infosend GSM | 2011 | 1 |
| K110334 | Waldo Patient Monitor | 2011 | 1 |
| K132803 | Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link | 2013 | 0 |
| K132148 | S Health | 2013 | 0 |
| K111922 | Vocare Myhealth Tablet | 2011 | 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 22 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 6 of the 60 ancestors have a recall of any class.
- Of its descendants, K124000 (Medapps Inc., Dba Alere Connect, 2013) has gone furthest, with 4 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. 2009, 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 MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off…
Read the full statement (212 words)
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083862: Medapps 2.0 Remote Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083862
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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