510(k) · Cleared
ClearedWellaho Personalized Outpatient Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanitas, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jan 16, 2013 as substantially equivalent to K113446 (Vignet, Inc., 2012) after a 48-day review. Its family tree reaches back 12 generations to 1987. 2 later devices descend from it.
- Decided
- Jan 16, 2013
- Review
- 48 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K864318 (1987). 26 ancestors in all, the oldest K790130 (1979). 2 later devices descend from it, 2 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 deviceK123671 Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK132173 Family HealthwareSanitas, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK130821 Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC · 2013
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 deviceK123671 Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView 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) | K123671 | Wellaho Personalized Outpatient Management System | Sanitas, Inc. | 2013 | — |
| +1 | K132173 | Family Healthware | Sanitas, Inc. | 2014 | — |
| +1 | K130821 | Intel-GE Care Innovations Connect RCM | Intel-Ge Care Innovations, LLC | 2013 | — |
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 | 1 | 0 |
| 2014 | 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? (1)
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 Manager | 2012 |
What descends from it? (2)
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 26 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K132173 (Sanitas, Inc., 2014) 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 WellahoTM Personalized Outpatient Management System is an accessory software application that is 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 usinig standard digital communication technologies 'and protocols. The Wellaho is also intended to be used in combination with…
Read the full statement (111 words)
The WellahoTM Personalized Outpatient Management System is an accessory software application that is 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 usinig standard digital communication technologies 'and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System 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/K123671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123671: Wellaho Personalized Outpatient Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123671
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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