510(k) · Cleared
ClearedConnected Care Clinical Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Watermark Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 14, 2012 as substantially equivalent to K072272 (Honeywell Hommed, LLC, 2007) after a 194-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Aug 14, 2012
- Review
- 194 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053453 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK053453 Hommed Central Station, Version 3.5Honeywell Hommed, LLC · 2006
- 1 generation backK072272 Honeywell Hommed Central Station 4.0Honeywell Hommed, LLC · 2007
- This deviceK120320 Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131203 Ihealth CloudAndon Health Co, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131203Ihealth CloudAndon Health Co, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053453 | Hommed Central Station, Version 3.5 | Honeywell Hommed, LLC | 2006 | — |
| −1 | K072272 | Honeywell Hommed Central Station 4.0 | Honeywell Hommed, LLC | 2007 | — |
| 0 (this device) | K120320 | Connected Care Clinical Application | Watermark Medical, Inc. | 2012 | — |
| +1 | K131203 | Ihealth Cloud | Andon Health Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K072272 | Honeywell Hommed Central Station 4.0Summary page 1…Ph: (262) 957-6797 Trade Name: Connected Care Clinical Application Predicate Device: Honeywell HomMed Central Station, K(072272 Common Name: Patient Vital Signs Monitor Viewing Station Classification Name:… | 2007 |
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 |
|---|---|---|---|
| K131203 | Ihealth Cloud | 2013 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131203 (Andon Health Co, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072272.
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. 2012, 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?
Clinical Application's intended use is to retrospectively receive, display and store monitored vital Signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120320: Connected Care Clinical Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120320
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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