510(k) · Cleared
ClearedFamily Healthware
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 May 30, 2014 as substantially equivalent to K123671 (Sanitas, Inc., 2013) after a 319-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- May 30, 2014
- Review
- 319 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K864318 (1987). 27 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 2 generations backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- 1 generation backK123671 Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013
- This deviceK132173 Family HealthwareSanitas, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 5 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 4 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 3 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 2 generations backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- 1 generation backK123671 Wellaho Personalized Outpatient Management SystemSanitas, Inc. · 2013
- This deviceK132173 Family HealthwareSanitas, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −5 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −4 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −3 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| −2 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| −1 | K123671 | Wellaho Personalized Outpatient Management System | Sanitas, Inc. | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K123671 | Wellaho Personalized Outpatient Management SystemSummary page 4…Il device Panel: Cardiovascular Devices Product code: DRG Predicate device: Wellaho Personalized Outpatient Management System Predicate Device Pro Code DRG Predicate K 123671 Date Summary Prepared: May 25, 2014 Device Description: Family Healthware™ is a Web-based software tool that can be used to as… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K123671.
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. 2014, 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?
Family Healthware™ is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132173: Family Healthware.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132173
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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