510(k) · Cleared

Cleared

Commander II

K043096510(k) TraditionalCleared Nov 24, 200415-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiocom · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Nov 24, 2004 as substantially equivalent to K010029 (Avid Care Corp., 2001) after a 15-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.

Decided: Nov 24, 2004
Review: 15 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010029 (2001). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010029 Home Health Monitoring SystemAvid Care Corp. · 2001
This deviceK043096 Commander IICardiocom · 2004
Descendant · cites it directly · 7 of its ownK053303 Cardiocom Commander IiiCardiocom, LLC · 2005
Descendant · 2 generations on · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
Descendant · 3 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
Descendant · 4 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
Descendant · 5 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005high 2 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all

K053303Cardiocom Commander IiiCardiocom, LLC · 2005 · cites it directly7descendants
K091579Foresee HomeNotal Vision, Ltd. · 2009 · 2 generations on4descendants
K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 3 generations on3descendants
K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 4 generations on2descendants
K180895AlleyeOculocare Medical AG · 2018 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010029	Home Health Monitoring System	Avid Care Corp.	2001	—
0 (this device)	K043096	Commander II	Cardiocom	2004	—
+1	K053303	Cardiocom Commander Iii	Cardiocom, LLC	2005	—
+2	K091579	Foresee Home	Notal Vision, Ltd.	2009	—
+3	K121738	Myvisiontrack (TM)	Vital Art and Science Incorporated	2013	—
+4	K143211	myVision Track Model 005	Vital Art and Science Incorporated	2015	—
+5	K180895	Alleye	Oculocare Medical AG	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	2	0
2013	1	0
2015	1	0
2018	1	0
2020	1	0
2022	1	0

FIG. 1 — Lineage of K043096, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K010029	Home Health Monitoring System Summary page 1 …Technological characteristics, comparison to predicate device. The Commander II is substantially equivalent to: Home Care Monitoring System, AvidCare Corp., K010029. The CommanderllIdevice and its predicate system have the same general use to provide the capability for health care profess…	Avid Care Corp.	2001	—

Also cleared against K010029: 4 other devices →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053303	Cardiocom Commander Iii	Cardiocom, LLC	2005	7

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?

Its one ancestor has no recall.
Of its descendants, K053303 (Cardiocom, LLC, 2005) has gone furthest, with 7 descendants of its own.
4 other devices also cite its predicate K010029.

How does its category compare?

All DXN devices

DXN 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

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)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 II 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/K043096 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043096: Commander II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043096

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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