510(k) · Cleared
ClearedMedtronic Commander Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Care Management Services · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 15, 2020 as substantially equivalent to K053303 (Cardiocom, LLC, 2005) and 2 other predicates after a 319-day review. Its family tree reaches back 16 generations to 1987.
- Decided
- May 15, 2020
- Review
- 319 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K864318 (1987). 65 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations between
- 3 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 2 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 1 generation backK122285 Tablet CommanderCardiocom, LLC · 2012
- This deviceK191745 Medtronic Commander FlexMedtronic Care Management Services · 2020
Show all 16 generations
- Root · 16 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 15 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 14 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 13 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 12 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 11 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 10 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 9 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 8 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 7 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 6 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 5 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 4 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 3 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 2 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 1 generation backK122285 Tablet CommanderCardiocom, LLC · 2012
- This deviceK191745 Medtronic Commander FlexMedtronic Care Management Services · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −15 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −14 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −13 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −12 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −11 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −10 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −9 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −8 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −7 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −6 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −5 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −4 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −2 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| −1 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| 0 (this device) | K191745 | Medtronic Commander Flex | Medtronic Care Management Services | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (3)
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 4…(Rx and OTC) Manufacturer Cardiocom, LLC Cardiocom LLC (now Medtronic) (now Medtronic) 510k number K053303, K091821 K122285 Regulation number 21 CFR 870.1130 21 CFR 870.2910 21 CFR 870.2700 P… | 2005 |
| * | K091821 | Commander 111, Model CD300-CD399Summary page 4…(Rx and OTC) Manufacturer Cardiocom, LLC Cardiocom LLC (now Medtronic) (now Medtronic) 510k number K053303, K091821 K122285 Regulation number 21 CFR 870.1130 21 CFR 870.2910 21 CFR 870.2700 ProCode… | 2009 |
| * | K122285 | Tablet CommanderSummary page 4…facturer Cardiocom, LLC Cardiocom LLC (now Medtronic) (now Medtronic) 510k number K053303, K091821 K122285 Regulation number 21 CFR 870.1130 21 CFR 870.2910 21 CFR 870.2700 ProCode DXN, DQA… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 65 ancestors have a recall of any class.
- 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. 2020, 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 Flex 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) between the patient, typically at home, and a health care professional at a remote site.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191745: Medtronic Commander Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191745
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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