510(k) · Cleared
ClearedConfidant 2.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confidant, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 16, 2007 as substantially equivalent to K062215 (Confidant, Inc., 2006) and 1 other predicate after a 53-day review. Its family tree reaches back 9 generations to 1987. 34 later devices descend from it.
- Decided
- Nov 16, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K864318 (1987). 23 ancestors in all, the oldest K790130 (1979). 34 later devices descend from it, 8 citing it directly.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 1 generation backK062215 Confidant 2.0Confidant, Inc. · 2006
- This deviceK072698 Confidant 2.5Confidant, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- Descendant · cites it directly · 4 of its ownK112559 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 5 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 4 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 1 generation backK062215 Confidant 2.0Confidant, Inc. · 2006
- This deviceK072698 Confidant 2.5Confidant, Inc. · 2007
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · cites it directly12descendants
- K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009 · cites it directly9descendants
- K113446Vignet Telehealth ManagerVignet, Inc. · 2012 · 2 generations on8descendants
- K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013 · 2 generations on4descendants
- K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −5 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −4 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −3 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −2 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −1 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| 0 (this device) | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| +1 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +1 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| +2 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| +2 | K124000 | Medapps 2.0 - Remote Patient Monitoring System | Medapps Inc., Dba Alere Connect | 2013 | — |
| +1 | K112559 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2011 | — |
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 |
|---|---|---|
| 2009 | 7 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 9 | 0 |
| 2014 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K062215 | Confidant 2.0Summary page 1…5 is substantially equivalent to the following legally marketed devices: Confidant 2.0 Honeywell HomMed Genesis K062215 OTC Monitor System Confidant Inc. K061087… | 2006 |
| * | K061087 | Genesis Otc MonitorSummary page 1…Honeywell HomMed Genesis K062215 OTC Monitor System Confidant Inc. K061087 Honeywell HomMed, LLC 3 Description of the device Confidant 2.5 is an… | 2006 |
What descends from it? (34)
See all 348 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083862 | Medapps 2.0 Remote Patient Monitoring System | 2009 | 12 |
| K092635 | Alcatel-Lucent Teleheath Manager | 2009 | 9 |
| K112559 | Medapps 2.0 Remote Patient Monitoring System | 2011 | 4 |
| K083221 | Aidera Diasend | 2009 | 3 |
| K101806 | Aidera Diasend System | 2010 | 2 |
| K090886 | RTX 3371 | 2009 | 2 |
| K083331 | Confidant, Model 2.6 | 2009 | 2 |
| K081499 | Health Manager, Version 1.1 | 2009 | 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 20 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K083862 (Medapps, Inc., 2009) has gone furthest, with 12 descendants of its own.
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. 2007, 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?
Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information…
Read the full statement (248 words)
Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.
Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.
Confidant 2.5 does not provide diagnosis of any disease or medical condition.
Confidant 2.5 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Confidant 2.5 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
Confidant 2.5 is intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072698: Confidant 2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072698
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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