510(k) · Cleared
ClearedMyhealthpoint Telehealth Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entra Health Systems · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Apr 14, 2014 as substantially equivalent to K113446 (Vignet, Inc., 2012) and 2 other predicates after a 208-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- Apr 14, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K864318 (1987). 29 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 backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 2 generations backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- 1 generation backK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
- This deviceK132930 Myhealthpoint Telehealth ManagerEntra Health Systems · 2014
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 backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 5 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 4 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 3 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 2 generations backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- 1 generation backK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
- This deviceK132930 Myhealthpoint Telehealth ManagerEntra Health Systems · 2014
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 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −5 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −4 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −3 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| −2 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| −1 | K122458 | Verizon Wireless Remote Health Management System | Cello Partnership D/B/A Verizon Wireless | 2013 | — |
| 0 (this device) | K132930 | Myhealthpoint Telehealth Manager | Entra Health Systems | 2014 | — |
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 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K113446 | Vignet Telehealth ManagerSummary page 4…Fax 619) 584 4504 Predicate #1 5 10(k) Number: K113446 Trade Name: Vignet TeleHealth Manager Manufacturer: Vigne… | 2012 |
| * | K101242 | Genesis DM Model: 6053000A1Summary page 1…th Manager G. Predicate Device(s): - Vignet TeleHealth Manager, KI 13446 - Honeywell Genesis DM Monitor, K101242 - Verizon Wireless Converged Health Management Device,… | 2010 |
| * | K122458 | Verizon Wireless Remote Health Management SystemSummary page 1…esis DM Monitor, K101242 - Verizon Wireless Converged Health Management Device, K122458 H. Common Name: Telernedicine System 1. Classification: Reg*Iatton_ - Product… | 2013 |
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 27 years and passes through 12 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 29 ancestors have a recall of any class.
- 4 other devices also cite its predicate K113446.
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 MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth…
Read the full statement (204 words)
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132930: Myhealthpoint Telehealth Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132930
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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