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., Dba Alere Connect · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 30, 2013 as substantially equivalent to K080798 (Intel Corp., 2008) and 2 other predicates after a 216-day review. Its family tree reaches back 13 generations to 1987. 4 later devices descend from it.
- Decided
- Jul 30, 2013
- Review
- 216 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K864318 (1987). 61 ancestors in all, the oldest K790130 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 1 generation backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- This deviceK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- Descendant · cites it directly · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · 2 generations on · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- Descendant · 2 generations on · 0 of its ownK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK132803 Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom…Medapps Inc., Dba Alere Connect · 2013
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 5 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 4 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 1 generation backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- This deviceK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
Most influential descendants
Showing 4 of 4 · See all- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · cites it directly2descendants
- K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022 · 2 generations on1descendant
- K252440EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025 · 2 generations on0descendants
- K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −5 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −4 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −3 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −1 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| 0 (this device) | K124000 | Medapps 2.0 - Remote Patient Monitoring System | Medapps Inc., Dba Alere Connect | 2013 | — |
| +1 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +2 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| +2 | K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025 | — |
| +1 | K132803 | Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link | Medapps Inc., Dba Alere Connect | 2013 | — |
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 |
|---|---|---|
| 2013 | 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 Legallv marketed predicate devices are: K080798 Intel Health Guide PHS6000 K040966 Carematix Modified System K083862 MedApps 2.0 - Remote Patient M… | 2008 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 1…70.2910, Product Code DRG) A. LEGALLY MARKETED PREDICATE DEVICE Legallv marketed predicate devices are: K080798 Intel Health Guide PHS6000 K040966 Carematix Modified System K083862 MedApps 2.0 - Remote Patient Monitoring System B. INDICATIONS FOR USE… | 2004 |
| * | K083862 | Medapps 2.0 Remote Patient Monitoring SystemSummary page 1…RKETED PREDICATE DEVICE Legallv marketed predicate devices are: K080798 Intel Health Guide PHS6000 K040966 Carematix Modified System K083862 MedApps 2.0 - Remote Patient Monitoring System B. INDICATIONS FOR USE The MedApps (Alere Connect) 2.0 - Remote P… | 2009 |
| † | K011779 | Avidcare Series 100 Telemanagement System | 2001 |
| † | K010029 | Home Health Monitoring System | 2001 |
What descends from it? (4)
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 26 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 61 ancestors have a recall of any class.
- Of its descendants, K181248 (Comarch Healthcare SA, 2018) has gone furthest, with 2 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. 2013, 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 (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL or MobileLink) an over-the-counter device that resides with the end-user (patient), which connects to commercially available FDA cleared accessory devices, specifically glucose meters, scales, blood pressure monitors, pulse oximeters, and PT/INR monitors and 2) web-based health data management application (MedApps'…
Read the full statement (351 words)
The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL or MobileLink) an over-the-counter device that resides with the end-user (patient), which connects to commercially available FDA cleared accessory devices, specifically glucose meters, scales, blood pressure monitors, pulse oximeters, and PT/INR monitors and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system.
MedlApps Inc., OBA Alere Connect Remote Patient Monitoring devices receive and store measurements collected from the described accessory devices, either wirelessly using short-range radio protocols (e.g. Bluetooth, Zlgbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) or tethered via cable (e.g. USE, serial, etc). Regardless of connectivity mode, the MedlApps / Alere Connect monitoring devices do not alter the indications for use of the described peripheral accessory health devices.
MedApps / Alere Connect devices indicate successful or failed data reception and transmission with visual and audio feedback using a combination of any of the following: OLED Display, LED Lights, verbal messages, and / or audio tones / chimes. MedApps / Alere Connedt devices store collected data and forward / transmit to server for access in HealthCOM via commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WIMax).
Healthcare professionals, clinicians and other authorized personnel can review the transmitted information within the MedApps HealthCOM system, where they can review collected readings, establish parameters to Indicate readings exceptions to set thresholds, or trigger Interactive Voice Response (IVR) messages to the patient remotely to issue Information such as reminders (e.g. "We haven't received readings from you today, please take and send your readings") or possibly educational Information for conditions such as diabetes, hypertension, CF-F, etc. Additionally, HeaithCOM can port collected data to the healthcare providers' clinical back-end system(s) of choice.
The MedApps 2.0 (Alere Connedt) - Remote Patient Monitoring System Is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide real-time / time-critical data. The device Is contraindlicated for patients requiring direct medical supervision or emergency Intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124000: 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/K124000
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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