510(k) · Cleared
ClearedOptum Telehealth Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optumhealth Care Solutions, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 23, 2013 as substantially equivalent to K113446 (Vignet, Inc., 2012) and 2 other predicates after a 198-day review. Its family tree reaches back 12 generations to 1987. 1 later device descends from it.
- Decided
- Oct 23, 2013
- Review
- 198 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K864318 (1987). 30 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations between
- 3 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 2 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 1 generation backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- This deviceK130971 Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK171406 Optum TeleHealth ApplicationUnited Health Group, Inc. · 2017
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 backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 4 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 3 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 2 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 1 generation backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- This deviceK130971 Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K171406Optum TeleHealth ApplicationUnited Health Group, Inc. · 2017 · cites it directly0descendants
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 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −4 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −3 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −2 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| −1 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| 0 (this device) | K130971 | Optum Telehealth Application | Optumhealth Care Solutions, Inc. | 2013 | — |
| +1 | K171406 | Optum TeleHealth Application | United Health Group, Inc. | 2017 | — |
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 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113446 | Vignet Telehealth ManagerSummary page 1…510(k) Number Vignet TeleHealth Manager Vignet Corporation KI 113446 Honeywell HomMed Honeywell HomMed LLC K1 12858 Genes… | 2012 |
| * | K112858 | Genesis Touch SystemSummary page 1…ration KI 113446 Honeywell HomMed Honeywell HomMed LLC K1 12858 GenesisTouchSystem ____________ ____________ Healthanywh… | 2012 |
| * | K091220 | Healthanywhere SystemSummary page 1…____________ Healthanywhere System Healthanywhere, Inc. K09 1220 Description of the Device The Optum TeleHealth Application is client/server software application which collects and transmits p… | 2009 |
| * | — | GenesisTouch System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171406 | Optum TeleHealth Application | 2017 | 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 26 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K171406 (United Health Group, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 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. 2013, 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 Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse oximetry, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the…
Read the full statement (126 words)
The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse oximetry, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application. The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.
The client application is available in two configurations:
* stand-alone application
* pre-loaded on an Android tablet
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130971 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130971: Optum Telehealth Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130971
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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