510(k) · Cleared
ClearedMedapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link
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 Dec 12, 2013 as substantially equivalent to K040966 (Carematix, Inc., 2004) and 2 other predicates after a 97-day review. Its family tree reaches back 14 generations to 1987.
- Decided
- Dec 12, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K864318 (1987). 62 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations between
- 3 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 2 generations backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- 1 generation backK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- This deviceK132803 Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom…Medapps Inc., Dba Alere Connect · 2013
Show all 14 generations
- Root · 14 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 13 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 12 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 11 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 10 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 9 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 8 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 7 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 6 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 5 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 4 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 3 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 2 generations backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- 1 generation backK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- This deviceK132803 Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom…Medapps Inc., Dba Alere Connect · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −13 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −12 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −11 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −10 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −9 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −8 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −7 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −6 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −5 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −4 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −3 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K040966 | Modification to Carematix Wellness SystemSummary page 10…CareMatix uses wireless connectivity to the hub whereas the MedlApps 2.0 System uses both wired and wireless connectivity to the hub. CareMatix System 5i0k (K040966) clearance summary letter includes the predicate Avid Care (K011779 and K010029) telemedicine system that connects to PT/IN… | 2004 |
| * | K083862 | Medapps 2.0 Remote Patient Monitoring SystemSummary page 7…MedApps; 2.0 Modified System Submission Submission Submission 1(040966 K083862 K(124000 (This Submission) Time Delay in Readings stored in Same… | 2009 |
| * | K124000 | Medapps 2.0 - Remote Patient Monitoring SystemSummary page 1…Legally marketed predicate devices are: K<040966 Carematix Modified System K<083862 MedApps 2.0 - Remote Patient Monitoring System K124000 MedlApps 2.0 - Remote Patient Monitoring System (with MobileLink added) B. INDICATIONS FOR USE The MedlApps (A… | 2013 |
| † | K011779 | Avidcare Series 100 Telemanagement System | 2001 |
| † | K010029 | Home Health Monitoring System | 2001 |
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 26 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 62 ancestors have a recall of any class.
- 15 other devices also cite its predicate K040966.
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, Alere MobileLink or Alere HomeLink) 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 (excluding HomeLink) and 2) web-based health data…
Read the full statement (353 words)
The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL, Alere MobileLink or Alere HomeLink) 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 (excluding HomeLink) and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system.
MedApps / 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, Zigbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) or tethered via cable (e.g. USB, serial, etc). Regardless of connectivity mode, the MedApps / 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: Display, LED Lights, verbal messages, and / or audio tones / chimes. MedApps / Alere Connect 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, CHF, etc. Additionally, HealthCOM can port collected data to the healthcare providers' clinical back-end system(s) of choice.
The MedApps /Alere Connect 2.0 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 contraindicated for patients requiring direct medical supervision or emergency intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132803: Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132803
Report an extraction error
Are you the manufacturer?
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