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. · DQA Oximeter
Cleared on Apr 20, 2006 as substantially equivalent to K050567 (Health Hero Network, Inc., 2005) and 5 other predicates after a 23-day review. Its family tree reaches back 9 generations to 1987. 39 later devices descend from it.
- Decided
- Apr 20, 2006
- Review
- 23 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K864318 (1987). 25 ancestors in all, the oldest K790130 (1979). 39 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 1 generation backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- This deviceK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · cites it directly · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · 2 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 3 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 5 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 4 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 1 generation backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- This deviceK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly30descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 2 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 3 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 3 generations on12descendants
- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −5 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −4 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −3 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −2 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −1 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| 0 (this device) | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +1 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +3 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +3 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
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 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 8 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K050567 | Health Buddy ApplianceSummary page 2…ons Health Buddy® Appliance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#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 (#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 (#K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Vit… | 2004 |
| * | K993128 | Healthbuddy with Device Connect [Glucose Meter]Summary page 2…uddy® Appliance PREDICATE DEVICES * Health Buddy® with Device Connectivity (#K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Viterion 100 TeleHealth Monitor (#K030419) DEVICE DESCRIPT… | 1999 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 2…Health Buddy® with Device Connectivity (#K050567, #K042273, #K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Viterion 100 TeleHealth Monitor (#K030419) DEVICE DESCRIPTION The Health Buddy appliance is a communications p… | 2004 |
| * | K030419 | Viterion 100 Telehealth MonitorSummary page 2…#K040086) * Health Buddy® with Buddylink (#K993128) * CareMatix Wellness System (#K040966) * Viterion 100 TeleHealth Monitor (#K030419) DEVICE DESCRIPTION The Health Buddy appliance is a communications product that connects to a telephone line. It is used by pat… | 2003 |
What descends from it? (39)
See all 396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063612 | Modification to Health Buddy Appliance | 2006 | 30 |
| K063484 | Patient Data Handler & Devices (PDH&D) | 2006 | 4 |
| K090801 | Electronic House Call | 2009 | 3 |
| K070543 | Modification to Health Buddy Appliance | 2007 | 2 |
| K080091 | Modification to:Health Buddy Appliance | 2008 | 1 |
| K091021 | Modification to Medicompass Connect | 2009 | 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 19 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K063612 (Health Hero Network, Inc., 2006) has gone furthest, with 30 descendants of its own.
- 6 other devices also cite its predicate K050567.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
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/K060843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060843: Modification to Health Buddy Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060843
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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