510(k) · Cleared
ClearedHommed Central Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hommed, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 22, 2002 after a 94-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.
- Decided
- Apr 22, 2002
- Review
- 94 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 2 citing it directly.
- This deviceK020184 Hommed Central StationHommed, LLC · 2002
- Descendant · cites it directly · 47 of its ownK040086 Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004
- Descendant · 2 generations on · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- Descendant · 2 generations on · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- Descendant · 2 generations on · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · 2 generations on · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K040086Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004 · cites it directly47descendants
- K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · 2 generations on45descendants
- K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · 2 generations on40descendants
- K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on39descendants
- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020184 | Hommed Central Station | Hommed, LLC | 2002 | — |
| +1 | K040086 | Health Buddy with Buddylink | Health Hero Network, Inc. | 2004 | — |
| +2 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| +2 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| +2 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +2 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 10 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | — | HomMed Observer, Model I Named without a submission number |
What descends from it? (66)
See all 662 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?
- Of its descendants, K040086 (Health Hero Network, Inc., 2004) has gone furthest, with 47 descendants of its own.
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 HomMed Central Station is intended to be used to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, Sp0O2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the…
Read the full statement (132 words)
The HomMed Central Station is intended to be used to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, Sp0O2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the monitored patient data, and the healthcare professional is responsible for the interpretation of the monitored data made available by the Observer. The Central Station data will be a utilized by the healthcare professional health including physicians and/or physician supervised nurses. Physiological data, system alerts and patient data analysis will be available to the health care provider from Central Station that may be considered as a retrospective data monitor system.
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/K020184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020184: Hommed Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020184
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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