510(k) · Cleared
ClearedCardiocom Commander Iii
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 K043096 (Cardiocom, 2004) after a 32-day review. Its family tree reaches back 2 generations to 2001. 7 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 2 generations to K010029 (2001). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010029 Home Health Monitoring SystemAvid Care Corp. · 2001
- 1 generation backK043096 Commander IICardiocom · 2004
- This deviceK053303 Cardiocom Commander IiiCardiocom, LLC · 2005
- Descendant · cites it directly · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- Descendant · 3 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- Descendant · 4 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018
- Descendant · cites it directly · 1 of its ownK091821 Commander 111, Model CD300-CD399Cardiocom, LLC · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091579Foresee HomeNotal Vision, Ltd. · 2009 · cites it directly4descendants
- K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 2 generations on3descendants
- K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 3 generations on2descendants
- K180895AlleyeOculocare Medical AG · 2018 · 4 generations on1descendant
- K091821Commander 111, Model CD300-CD399Cardiocom, LLC · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010029 | Home Health Monitoring System | Avid Care Corp. | 2001 | — |
| −1 | K043096 | Commander II | Cardiocom | 2004 | — |
| 0 (this device) | K053303 | Cardiocom Commander Iii | Cardiocom, LLC | 2005 | — |
| +1 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| +2 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| +3 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
| +4 | K180895 | Alleye | Oculocare Medical AG | 2018 | — |
| +1 | K091821 | Commander 111, Model CD300-CD399 | Cardiocom, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K043096 | Commander IISummary page 1…System 2. Equivalent legally marketed devices This product is similar in function and design to predicate K043096 Cardiocom LLC Commander IL. 3. Indicatio… | 2004 |
What descends from it? (7)
3 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091579 (Notal Vision, Ltd., 2009) has gone furthest, with 4 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 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.
Contraindications, Precautions and Warnings:
The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053303: Cardiocom Commander Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053303
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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