510(k) · Cleared
ClearedHealthinterlink Beacon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthinterlink, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Mar 14, 2014 as substantially equivalent to K112559 (Medapps, Inc., 2011) and 3 other predicates after a 143-day review. Its family tree reaches back 16 generations to 1987. 3 later devices descend from it.
- Decided
- Mar 14, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K864318 (1987). 71 ancestors in all, the oldest K790130 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations between
- 3 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 2 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 1 generation backK122285 Tablet CommanderCardiocom, LLC · 2012
- This deviceK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · cites it directly · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · 2 generations on · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- Descendant · 2 generations on · 0 of its ownK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
Show all 16 generations
- Root · 16 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 15 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 14 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 13 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 12 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 11 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 10 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 9 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 8 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 7 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 6 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 5 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 4 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 3 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 2 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 1 generation backK122285 Tablet CommanderCardiocom, LLC · 2012
- This deviceK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −15 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −14 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −13 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −12 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −11 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −10 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −9 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −8 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −7 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −6 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −5 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −4 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −2 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| −1 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| 0 (this device) | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +1 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +2 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| +2 | K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025 | — |
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 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K112559 | Medapps 2.0 Remote Patient Monitoring System | 2011 |
| * | K112858 | Genesis Touch System | 2012 |
| * | K122285 | Tablet CommanderSummary page 1…L, New, OQA, JOP 4. Predicate Device Information: KI 12559 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM KI 12858 GENESIS TOUCH SYSTEM K122285 TABLET COMMANDER K103276 INTEL HEALTH GUIDE EXPRESS 5. Device Descrip~tion: The Heaithinterlink… | 2012 |
| * | K103276 | Intel Health GuideSummary page 1…ce Information: KI 12559 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM KI 12858 GENESIS TOUCH SYSTEM K122285 TABLET COMMANDER K103276 INTEL HEALTH GUIDE EXPRESS 5. Device Descrip~tion: The Heaithinterlink Beacon is a software application. Once… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181248 | Comarch e-Care Platform | 2018 | 2 |
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 27 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 71 ancestors have a recall of any class.
- Of its descendants, K181248 (Comarch Healthcare SA, 2018) has gone furthest, with 2 descendants of its own.
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. 2014, 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 HealthInterlink® Beacon® device is for use by patients to collect and transmit general health information, physiological measurements such as blood pressure, temperature, weight, glucose and SpO2 using commercially available FDA cleared wireless medical devices designed for home use, and other data between themselves and a caregiver.
The HealthInterlink® Beacon® makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. HealthInterlink® Beacon® is not intended as a substitute for medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133252: Healthinterlink Beacon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133252
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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