510(k) · Cleared
ClearedCommander 111, Model CD300-CD399
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 Aug 25, 2009 as substantially equivalent to K053303 (Cardiocom, LLC, 2005) after a 68-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Aug 25, 2009
- Review
- 68 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010029 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK010029 Home Health Monitoring SystemAvid Care Corp. · 2001
- 2 generations backK043096 Commander IICardiocom · 2004
- 1 generation backK053303 Cardiocom Commander IiiCardiocom, LLC · 2005
- This deviceK091821 Commander 111, Model CD300-CD399Cardiocom, LLC · 2009
- Descendant · cites it directly · 0 of its ownK191745 Medtronic Commander FlexMedtronic Care Management Services · 2020
Most influential descendants
Showing 1 of 1 · See all- K191745Medtronic Commander FlexMedtronic Care Management Services · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010029 | Home Health Monitoring System | Avid Care Corp. | 2001 | — |
| −2 | K043096 | Commander II | Cardiocom | 2004 | — |
| −1 | K053303 | Cardiocom Commander Iii | Cardiocom, LLC | 2005 | — |
| 0 (this device) | K091821 | Commander 111, Model CD300-CD399 | Cardiocom, LLC | 2009 | — |
| +1 | K191745 | Medtronic Commander Flex | Medtronic Care Management Services | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K053303 | Cardiocom Commander IiiSummary page 1…DXN, DQA Predicate Device(s): The subject device is equivalent to the following device: Cardiocom Commander III, K053303 Device Description: The Commander III is an FDA cleared device (K053303, K053304).… | 2005 |
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 |
|---|---|---|---|
| K191745 | Medtronic Commander Flex | 2020 | 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 8 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191745 (Medtronic Care Management Services, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053303.
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. 2009, 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?
The Commander III 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/K091821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091821: Commander 111, Model CD300-CD399.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091821
Report an extraction error
Are you the manufacturer?
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