510(k) · Cleared
ClearedAlcatel-Lucent Teleheath Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcatel-Lucent Canada, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Sep 10, 2009 as substantially equivalent to K040966 (Carematix, Inc., 2004) and 1 other predicate after a 14-day review. Its family tree reaches back 10 generations to 1987. 9 later devices descend from it.
- Decided
- Sep 10, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K864318 (1987). 24 ancestors in all, the oldest K790130 (1979). 9 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations between
- 3 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 2 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 1 generation backK072698 Confidant 2.5Confidant, Inc. · 2007
- This deviceK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK113446 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 · 2 generations on · 2 of its ownK123671 Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK130971 Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK171406 Optum TeleHealth ApplicationUnited Health Group, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 8 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 7 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 6 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 5 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 4 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 3 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 2 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 1 generation backK072698 Confidant 2.5Confidant, Inc. · 2007
- This deviceK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113446Vignet Telehealth ManagerVignet, Inc. · 2012 · cites it directly8descendants
- K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013 · cites it directly2descendants
- K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013 · 2 generations on2descendants
- K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013 · 2 generations on1descendant
- K171406Optum TeleHealth ApplicationUnited Health Group, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −9 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −8 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −7 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −6 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −5 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −4 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −3 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −2 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −1 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| 0 (this device) | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| +1 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| +1 | K122458 | Verizon Wireless Remote Health Management System | Cello Partnership D/B/A Verizon Wireless | 2013 | — |
| +2 | K123671 | Wellaho Personalized Outpatient Management System | Sanitas, Inc. | 2013 | — |
| +2 | K130971 | Optum Telehealth Application | Optumhealth Care Solutions, Inc. | 2013 | — |
| +3 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K040966 | Modification to Carematix Wellness SystemSummary page 2…e Alcatel-Lucent TeleHealth Manager device is substantially equivalent to the following two FDA cleared predicate devices: 510(k) Number: K040966 Trade Name: Carematix Wellness System Manufacturer: Carematix, Inc. Class… | 2004 |
| * | K072698 | Confidant 2.5Summary page 2…SE with respect to: Indications for use, performance and technological characteristics 510(k) Number: K072698 Trade Name: Confidant 2.5 Manufacturer: Confidant International, LLC Clas… | 2007 |
What descends from it? (9)
2 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 22 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K113446 (Vignet, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 15 other devices also cite its predicate K040966.
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. 2009, 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?
Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner. The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure…
Read the full statement (147 words)
Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner.
The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements.
The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform, which stores the information and allows its remote access by the patient and/or health care professional.
Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092635: Alcatel-Lucent Teleheath Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092635
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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