510(k) · Cleared
ClearedCommander Iii Non-Invasive Blood Pressure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocom, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 30, 2005 as substantially equivalent to K982481 (A&D Engineering, Inc., 1998) after a 32-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.
- Decided
- Dec 30, 2005
- Review
- 32 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982481 (1998). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- This deviceK053304 Commander Iii Non-Invasive Blood Pressure SystemCardiocom, LLC · 2005
- Descendant · cites it directly · 5 of its ownK122285 Tablet CommanderCardiocom, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · 3 generations on · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · 4 generations on · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- Descendant · 4 generations on · 0 of its ownK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122285Tablet CommanderCardiocom, LLC · 2012 · cites it directly5descendants
- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · 2 generations on3descendants
- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · 3 generations on2descendants
- K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022 · 4 generations on1descendant
- K252440EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| 0 (this device) | K053304 | Commander Iii Non-Invasive Blood Pressure System | Cardiocom, LLC | 2005 | — |
| +1 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| +2 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +3 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +4 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| +4 | K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K982481 | A&D Medical UA-767PC Digital Blood Pressure MonitorSummary page 1…System 2. Equivalent legally marketed devices This product is similar in function and design to predicate K982481 A&D Medical UA- 767PC Digital Blood Pressure Monito… | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122285 | Tablet Commander | 2012 | 5 |
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?
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 Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053304: Commander Iii Non-Invasive Blood Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053304
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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