510(k) · Cleared

Cleared

Carematix Wellness System

K031840510(k) TraditionalCleared Oct 10, 2003116-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

Carematix, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Oct 10, 2003 as substantially equivalent to K023749 (Philips Medical Systems, 2002) and 3 other predicates after a 116-day review. Its family tree reaches back 5 generations to 1987. 90 later devices descend from it.

Decided: Oct 10, 2003
Review: 116 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K864318 (1987). 14 ancestors in all, the oldest K790130 (1979). 90 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
4 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
3 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
2 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
1 generation backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
This deviceK031840 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
Descendant · 2 generations on · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006

Showing 5 of 90 descendants. See all descendants

Descendants cleared per year

2004high 13 (2013) · low 0 (2016)2026

Most influential descendants

Showing 5 of 90 · See all

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
K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K864318	The Buddy System/Health Information System	The Buddy Systems, Inc.	1987	—
−4	K952979	Hanc Network	Healthtech Services Corp.	1996	—
−3	K964408	Poseidon Cardiac Monitoring System (PCMS)	Instromedix, Inc.	1997	—
−2	K993169	Modification of: Physiological Signal Transmitter and Receiver, Model 3810A	Hewlett-Packard Co.	1999	—
−1	K023749	The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)	Philips Medical Systems	2002	—
0 (this device)	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	—
+2	K060843	Modification to Health Buddy Appliance	Health Hero Network, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1987	2	0
1988	1	0
1993	1	0
1995	1	0
1996	1	0
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	3	0
2006	10	0
2007	5	0
2008	6	0
2009	12	0
2010	7	0
2011	10	0
2012	6	0
2013	13	0
2014	5	0
2015	1	0
2017	3	0
2018	3	0
2020	1	0
2022	2	0
2025	1	0

FIG. 1 — Lineage of K031840, 1987–2025Source: 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? (4)

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
*	K023749	The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)	Philips Medical Systems	2002	—
*	K993169	Modification of: Physiological Signal Transmitter and Receiver, Model 3810A Summary page 1 …valent legally marketed devices: This product is similar in function to the M3810a Philips Telemonitoring System, KO23749 and Hewlett Packard Company Model 38 1OA, K993 169; AvidCare Series 100 Telemanagement System, KO 11779; AvidCare Corporation Home Health Monitoring System, KO 10029. The Carema…	Hewlett-Packard Co.	1999	—
*	K011779	Avidcare Series 100 Telemanagement System	Avid Care Corp.	2001	—
*	K010029	Home Health Monitoring System	Avid Care Corp.	2001	—

Also cleared against K023749: 9 other devices →

What descends from it? (90)

See all 90

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

Number	Device	Applicant	Decided	Descendants
K040966	Modification to Carematix Wellness System	Carematix, Inc.	2004	86
K051470	Remote Care Management Systems (RCMS)	Bl Healthcare, Inc.	2005	21
K060504	Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001	Ideal Life, Inc.	2006	5
K083046	Fora Telehealth System	Taidoc Technology Corporation	2009	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 16 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K040966 (Carematix, Inc., 2004) has gone furthest, with 86 descendants of its own.
9 other devices also cite its predicate K023749.

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 Carematix Wellness System is intended for patient home use for the following:

Non-invasive blood pressure measurement;

Measurement of blood glucose;

Patient weight using a stand-on electronic scale

The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient’s home setting.

Prescription Device.

Federal law (US) restricts this device to sale by or on the order of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031840 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031840: Carematix Wellness System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031840

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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