510(k) · Cleared
ClearedVignet Telehealth Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vignet, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 16, 2012 as substantially equivalent to K092635 (Alcatel-Lucent Canada, Inc., 2009) and 2 other predicates after a 238-day review. Its family tree reaches back 11 generations to 1987. 8 later devices descend from it.
- Decided
- Jul 16, 2012
- Review
- 238 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K864318 (1987). 25 ancestors in all, the oldest K790130 (1979). 8 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 2 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 1 generation backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- This deviceK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
- Descendant · cites it directly · 2 of its ownK123671 Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK130971 Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK171406 Optum TeleHealth ApplicationUnited Health Group, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK132173 Family HealthwareSanitas, Inc. · 2014
Show all 11 generations
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 9 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 8 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 7 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 6 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 5 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 4 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 3 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 2 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 1 generation backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- This deviceK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013 · cites it directly2descendants
- K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013 · cites it directly2descendants
- K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013 · cites it directly1descendant
- K171406Optum TeleHealth ApplicationUnited Health Group, Inc. · 2017 · 2 generations on0descendants
- K132173Family HealthwareSanitas, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −10 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −9 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −8 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −7 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −6 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −5 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −4 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −3 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −2 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −1 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| 0 (this device) | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| +1 | K122458 | Verizon Wireless Remote Health Management System | Cello Partnership D/B/A Verizon Wireless | 2013 | — |
| +1 | K123671 | Wellaho Personalized Outpatient Management System | Sanitas, Inc. | 2013 | — |
| +1 | K130971 | Optum Telehealth Application | Optumhealth Care Solutions, Inc. | 2013 | — |
| +2 | K171406 | Optum TeleHealth Application | United Health Group, Inc. | 2017 | — |
| +2 | K132173 | Family Healthware | Sanitas, Inc. | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K092635 | Alcatel-Lucent Teleheath ManagerSummary page 1…igriet TeleHealth Manager device is substantially equivalent to the following FDA cleared predicate device: 510(k) Number: K092635 Proprietary Name: Alcatel-Lucent Telel-ealth Manager Classification Name:… | 2009 |
| * | K011779 | Avidcare Series 100 Telemanagement SystemSummary page 2…(mmHg), Pulse A&D Engineering, Inc. / Model UA- (K092635) (BPM) 851-PBT Avid Care (K011779) Fora Care, Inc. - Taidoc Technology Carematix (K040966)… | 2001 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 2…851-PBT Avid Care (K011779) Fora Care, Inc. - Taidoc Technology Carematix (K040966) Corporation / Model TD-3250C (K1… | 2004 |
What descends from it? (8)
5 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 25 years and passes through 10 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K122458 (Cello Partnership D/B/A Verizon Wireless, 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K092635.
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. 2012, 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 Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with…
Read the full statement (111 words)
The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113446: Vignet 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/K113446
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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