510(k) · Cleared

Cleared

Home Health Monitoring System

K010029510(k) TraditionalCleared Jun 29, 2001177-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

Avid Care Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jun 29, 2001 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 105 later devices descend from it.

Decided: Jun 29, 2001
Review: 177 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

105 later devices descend from it, 5 citing it directly.

This deviceK010029 Home Health Monitoring SystemAvid Care Corp. · 2001
Descendant · cites it directly · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003
Descendant · cites it directly · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
Descendant · 2 generations on · 45 of its ownK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
Descendant · 2 generations on · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
Descendant · 2 generations on · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005

Showing 5 of 105 descendants. See all descendants

Descendants cleared per year

2003high 13 (2009) · low 0 (2019)2026

Most influential descendants

Showing 5 of 105 · See all

K031840Carematix Wellness SystemCarematix, Inc. · 2003 · cites it directly90descendants
K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · cites it directly86descendants
K050929The Hermes SystemPalaistra Systems, Inc. · 2005 · 2 generations on45descendants
K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · 2 generations on45descendants
K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · 2 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010029	Home Health Monitoring System	Avid Care Corp.	2001	—
+1	K031840	Carematix Wellness System	Carematix, Inc.	2003	—
+1	K040966	Modification to Carematix Wellness System	Carematix, Inc.	2004	—
+2	K050929	The Hermes System	Palaistra Systems, Inc.	2005	—
+2	K042273	Modification to Health Buddy with Device Connectivity	Health Hero Network, Inc.	2004	—
+2	K050567	Health Buddy Appliance	Health Hero Network, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	4	0
2005	6	0
2006	10	0
2007	6	0
2008	6	0
2009	13	0
2010	8	0
2011	10	0
2012	7	0
2013	13	0
2014	5	0
2015	2	0
2016	1	0
2017	4	0
2018	3	0
2020	1	0
2022	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K010029, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (105)

See all 105

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031840	Carematix Wellness System	Carematix, Inc.	2003	90
K040966	Modification to Carematix Wellness System	Carematix, Inc.	2004	86
K051470	Remote Care Management Systems (RCMS)	Bl Healthcare, Inc.	2005	21
K020534	Medstar System, Models 533-300	Cybernet Medical	2003	10
K043096	Commander II	Cardiocom	2004	8

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?

Of its descendants, K031840 (Carematix, Inc., 2003) has gone furthest, with 90 descendants of its own.

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	—

https://510kreport.com/device/K010029 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010029: Home Health Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010029

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026