510(k) · Cleared
ClearedHommed Central Station, Version 3.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Honeywell Hommed, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 5, 2006 after a 144-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- May 5, 2006
- Review
- 144 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK053453 Hommed Central Station, Version 3.5Honeywell Hommed, LLC · 2006
- Descendant · cites it directly · 3 of its ownK072272 Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC · 2007
- Descendant · 2 generations on · 1 of its ownK120320 Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK153719 LifeStream Management System, LifeStream Management Suite…Honeywell Hommed, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK131203 Ihealth CloudAndon Health Co, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K072272Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC · 2007 · cites it directly3descendants
- K120320Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012 · 2 generations on1descendant
- K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager…Honeywell Hommed, LLC · 2016 · 2 generations on0descendants
- K131203Ihealth CloudAndon Health Co, Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053453 | Hommed Central Station, Version 3.5 | Honeywell Hommed, LLC | 2006 | — |
| +1 | K072272 | Honeywell Hommed Central Station 4.0 | Honeywell Hommed, LLC | 2007 | — |
| +2 | K120320 | Connected Care Clinical Application | Watermark Medical, Inc. | 2012 | — |
| +2 | K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient… | Honeywell Hommed, LLC | 2016 | — |
| +3 | K131203 | Ihealth Cloud | Andon Health Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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? (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 Central Station Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072272 | Honeywell Hommed Central Station 4.0 | 2007 | 3 |
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, K072272 (Honeywell Hommed, LLC, 2007) has gone furthest, with 3 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?
Central Station's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. The Central Station displays the data and system alerts for review and interpretation by a healthcare professional. Central Station is not intended for emergency use or real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053453: Hommed Central Station, Version 3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053453
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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