510(k) · Cleared
Recalled · 2009Well@Home System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoe Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 2, 2004 as substantially equivalent to K952979 (Healthtech Services Corp., 1996) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 2, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864318 (1987). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 1 generation backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- This deviceK040012 Well@Home SystemZoe Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK100913 Iqvitals and Iqvitals SystemBrentwood Medical Technology Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K100913Iqvitals and Iqvitals SystemBrentwood Medical Technology Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −1 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| 0 (this device) | K040012 | Well@Home System | Zoe Medical, Inc. | 2004 | — |
| +1 | K100913 | Iqvitals and Iqvitals System | Brentwood Medical Technology Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K952979 | Hanc NetworkSummary page 1…Measurement System (per 21 CFR 870.1130) Predicate Devices Overall Predicate Device: HealthTech HANC (Home Assisted Nursing Care) Network 510(k) number K952979 Vital Signs Predicate Devices: Zoe Medical Nightingale Monitoring System 510(k) number K001775… | 1996 |
| * | K001775 | Zoe Medical Nightingale Monitoring SystemSummary page 1…ssisted Nursing Care) Network 510(k) number K952979 Vital Signs Predicate Devices: Zoe Medical Nightingale Monitoring System 510(k) number K001775 (for measuring noninvasive blood pressure, oxygen saturation, pulse rate, temperatu… | 2001 |
| * | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsSummary page 1…rate, temperature, respiration rate, heart rate, and ECG) Lifescan One Touch Ultra 510(k) number K024194 (for measuring blood glucose level) Zoe Medical, Incorporated Phone: (978… | 2003 |
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 |
|---|---|---|---|
| K100913 | Iqvitals and Iqvitals System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2009 | Not classified | Z-2166-2010 | Component change control | Touch panel may become unresponsive. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K100913 (Brentwood Medical Technology Corp., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K952979.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Well@Home System is indicated for use for patients who need home-based health care from professional clinicians. The system provides benefits for patients who need periodic remote monitoring of their vital signs (such as noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, or ECG) or self-reported symptoms, who need reminders to take prescribed medications, or who need training about how to manage their illness.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040012: Well@Home System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040012
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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