510(k) · Cleared
ClearedMobilecare Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aframe Digital, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 19, 2012 as substantially equivalent to K103796 (Telemedcare Pty, Ltd., 2011) after a 109-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- Nov 19, 2012
- Review
- 109 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K864318 (1987). 63 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- 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 backK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
- This deviceK122333 Mobilecare MonitorAframe Digital, Inc. · 2012
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 backK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
- This deviceK122333 Mobilecare MonitorAframe Digital, Inc. · 2012
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 | K103796 | Telemedcare Health Monitor | Telemedcare Pty, Ltd. | 2011 | — |
| 0 (this device) | K122333 | Mobilecare Monitor | Aframe Digital, Inc. | 2012 | — |
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 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K103796 | Telemedcare Health MonitorSummary page 1…el: Cardiovascular Substantial Equivalence: Substantial Equivalence is claimed with respect to the following predicate device: K103796 TeleMedCare Health Monitor In addition, since the Class II functionality described in this PMN is being added to our previou… | 2011 |
| † | K090138 | Mobilecare Monitor, Model 2100 | 2009 |
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 25 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 63 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. 2012, 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 MobileCare MonitorM remote monitoring system is intended as a support in the care of patients and the elderly in institutional, home, and community care settings. Intended users include the monitored individuals and their caregivers. MobileCare Monitor includes a MyPHD T personal help device that is intended to monitor patients and the elderly as they go about their daily activities. MyPHO can be affixed to the wrist, clipped to the waist or used in…
Read the full statement (345 words)
The MobileCare MonitorM remote monitoring system is intended as a support in the care of patients and the elderly in institutional, home, and community care settings. Intended users include the monitored individuals and their caregivers.
MobileCare Monitor includes a MyPHD T personal help device that is intended to monitor patients and the elderly as they go about their daily activities. MyPHO can be affixed to the wrist, clipped to the waist or used in a bandage for attachment at other locations on the monitored individual, as determined by the patient or caregiver. MobileCare monitor provides the MyPHO location information, battery life and indication that it is being worn. MyPHO also includes a help button and a tn-axial accelerometer used to convey the degree of motion created by a wearer's movements to support an assessment of impacts.
MobileCare Monitor may also relay physiological data from legally marketed Class I and Class II wireless medical devices (e.g. blood pressure cuff, weight scale, blood glucometer, pulse-oximeter, etc.) to AlFrame Digital secure remote servers by means of industry standard networks and public carriers. Physiological data transmitted from these devices are stored and may be retrieved with a secure web browser after the user presents satisfactory security credentials. Users may also request the data to be presented in graphical format.
Alerts can be sent when a patient presses a help button on the myPHD or when any data value from MyPHD or relayed device exceeds an upper or lower limit threshold established by a user. These data include impact sensitivity settings and/or physiological measurements from relayed Class I and Class 11 devices. Rules may be created for reminders to be scheduled for periodic physiological measurements. Alerts are sent to the browser or to a computer or mobile device address that the user designates.
MobileCare Monitor is not interpretive or predictive, nor is it intended to provide an automated treatment decision or act as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122333: Mobilecare Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122333
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