510(k) · Cleared
ClearedModification to Intel Health Guide, Model PHS6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intel Corp. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 26, 2008 as substantially equivalent to K080798 (Intel Corp., 2008) after a 36-day review. Its family tree reaches back 12 generations to 1987. 12 later devices descend from it.
- Decided
- Nov 26, 2008
- Review
- 36 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K864318 (1987). 51 ancestors in all, the oldest K790130 (1979). 12 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations between
- 3 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- This deviceK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · cites it directly · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- Descendant · cites it directly · 10 of its ownK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- Descendant · 2 generations on · 5 of its ownK122285 Tablet CommanderCardiocom, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
Show all 12 generations
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 10 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 9 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 8 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 7 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 6 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 5 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 4 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 3 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- This deviceK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · cites it directly11descendants
- K103276Intel Health GuideIntel Corporation Digital Health Group · 2011 · cites it directly10descendants
- K122285Tablet CommanderCardiocom, LLC · 2012 · 2 generations on5descendants
- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · 2 generations on3descendants
- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −11 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −10 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −9 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −8 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −7 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −6 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −5 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −4 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −3 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −2 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −1 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| 0 (this device) | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +1 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| +1 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| +2 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| +2 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +2 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K080798 | Intel Health Guide, Model: PHS6000Summary page 1…Radiofrequency (21 CFR 870.2910, Product Code DRG) Substantial Equivalence is claimed to the following device: Intel Corporation's Intel® Health Guide PHS6000 (K080798) Device Description The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sig… | 2008 |
What descends from it? (12)
See all 122 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 21 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 6 of the 51 ancestors have a recall of any class.
- Of its descendants, K101178 (Intel Corp., 2010) has gone furthest, with 11 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. 2008, 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 Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and…
Read the full statement (196 words)
The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083115: Modification to Intel Health Guide, Model PHS6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083115
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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