510(k) · Cleared
ClearedHoneywell Hommed Central Station 4.0
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 Sep 7, 2007 as substantially equivalent to K053453 (Honeywell Hommed, LLC, 2006) after a 23-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Sep 7, 2007
- Review
- 23 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053453 (2006). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK053453 Hommed Central Station, Version 3.5Honeywell Hommed, LLC · 2006
- This deviceK072272 Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC · 2007
- Descendant · cites it directly · 1 of its ownK120320 Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK153719 LifeStream Management System, LifeStream Management Suite…Honeywell Hommed, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK131203 Ihealth CloudAndon Health Co, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K120320Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012 · cites it directly1descendant
- K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager…Honeywell Hommed, LLC · 2016 · cites it directly0descendants
- K131203Ihealth CloudAndon Health Co, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053453 | Hommed Central Station, Version 3.5 | Honeywell Hommed, LLC | 2006 | — |
| 0 (this device) | K072272 | Honeywell Hommed Central Station 4.0 | Honeywell Hommed, LLC | 2007 | — |
| +1 | K120320 | Connected Care Clinical Application | Watermark Medical, Inc. | 2012 | — |
| +1 | K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient… | Honeywell Hommed, LLC | 2016 | — |
| +2 | K131203 | Ihealth Cloud | Andon Health Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K053453 | Hommed Central Station, Version 3.5Summary page 1…Fax: (262) 252-6105 Trade Name: Central Station, Version 4.0 Predicate Device: HomMed Central Station, Version 3.5, K053453 Common Name: Patient Vital Signs Monitor Viewing Station Classification Name: Non-Invasive Blood… | 2006 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K120320 (Watermark Medical, Inc., 2012) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.
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. 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/K072272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072272: Honeywell Hommed Central Station 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072272
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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