510(k) · Cleared
ClearedModification to Health Buddy Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Hero Network, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 29, 2006 as substantially equivalent to K060843 (Health Hero Network, Inc., 2006) and 6 other predicates after a 25-day review. Its family tree reaches back 10 generations to 1987. 30 later devices descend from it.
- Decided
- Dec 29, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K864318 (1987). 28 ancestors in all, the oldest K790130 (1979). 30 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations between
- 3 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 2 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 1 generation backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- This deviceK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · cites it directly · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 2 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 2 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · 2 generations on · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- Descendant · 2 generations on · 10 of its ownK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
Show all 10 generations
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 8 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 7 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 6 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 5 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 4 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 3 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 2 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 1 generation backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- This deviceK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · cites it directly25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 2 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 2 generations on12descendants
- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · 2 generations on11descendants
- K103276Intel Health GuideIntel Corporation Digital Health Group · 2011 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −9 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −8 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −7 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −6 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −5 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −4 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −3 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −2 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −1 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| 0 (this device) | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +1 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +2 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +2 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +2 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| +2 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (7)
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 |
|---|---|---|---|
| * | K060843 | Modification to Health Buddy ApplianceSummary page 2…fications Health Buddy® Appliance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#K060843, #K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System… | 2006 |
| * | K050567 | Health Buddy ApplianceSummary page 2…Health Buddy® Appliance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#K060843, #K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966… | 2005 |
| * | K042273 | Modification to Health Buddy with Device ConnectivitySummary page 2…Health Buddy® Appliance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#K060843, #K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) *… | 2004 |
| * | K040086 | Health Buddy with BuddylinkSummary page 2…Health Buddy® Appliance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#K060843, #K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Philips TeleMonito… | 2004 |
| * | K993128 | Healthbuddy with Device Connect [Glucose Meter]Summary page 2…ance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#K060843, #K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Philips TeleMonitoring System, (#K041674) DEVICE DESCRIPTION The Hea… | 1999 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 2…y® with Device Connectivity (#K060843, #K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Philips TeleMonitoring System, (#K041674) DEVICE DESCRIPTION The Health Buddy appliance is a communications product… | 2004 |
| * | K041674 | The M3810A Philips Telemonitoring System with M3814A SPO2 UnitSummary page 2…2273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Philips TeleMonitoring System, (#K041674) DEVICE DESCRIPTION The Health Buddy appliance is a communications product that connects to a telephone line. It is used by pati… | 2004 |
What descends from it? (30)
See all 306 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 19 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K080798 (Intel Corp., 2008) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K060843.
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.
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?
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063612: Modification to Health Buddy Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063612
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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