510(k) · Cleared

Cleared

Health Buddy with Buddylink

K040086510(k) TraditionalCleared Mar 10, 200454-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

Health Hero Network, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 10, 2004 as substantially equivalent to K993128 (Health Hero Network, Inc., 1999) and 3 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1995. 47 later devices descend from it.

Decided: Mar 10, 2004
Review: 54 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K950727 (1995). 4 ancestors in all. 47 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
This deviceK040086 Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004
Descendant · cites it directly · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
Descendant · cites it directly · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
Descendant · cites it directly · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Descendant · cites it directly · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Descendant · 2 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2004high 8 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 47 · See all

K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · cites it directly45descendants
K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · cites it directly40descendants
K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly39descendants
K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly30descendants
K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 2 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950727	One Touch Profile Complete Diabetes Tracking System	Lifescan, Inc.	1995	—
0 (this device)	K040086	Health Buddy with Buddylink	Health Hero Network, Inc.	2004	—
+1	K042273	Modification to Health Buddy with Device Connectivity	Health Hero Network, Inc.	2004	—
+1	K050567	Health Buddy Appliance	Health Hero Network, Inc.	2005	—
+1	K060843	Modification to Health Buddy Appliance	Health Hero Network, Inc.	2006	—
+1	K063612	Modification to Health Buddy Appliance	Health Hero Network, Inc.	2006	—
+2	K080798	Intel Health Guide, Model: PHS6000	Intel Corp.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2002	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K040086, 1995–2025Source: 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
*	K993128	Healthbuddy with Device Connect [Glucose Meter] Summary page 1 …R 862.1245) Device Panel: 75, Clinical Chemistry Device Classification: Class II PREDICATE DEVICES · Health Buddy® with Buddylink (K993128) * In Touch Diabetes Management Software (K984527) · HomMed Central Station (K020184) DEVICE DESCRIPTION The He…	Health Hero Network, Inc.	1999	—
*	K950727	One Touch Profile Complete Diabetes Tracking System Summary page 2 …e substantially equivalent to the cleared Health Buddy device (#K993128). The device is substantially equivalent to LifeScan ONE TOUCH Profile Diabetes Tracking System (#K950727) and the LifeScan INTOUCH Diabetes Management Software (#K984527), and HomMed Central Station (#K020184). CONCLUSION The Health…	Lifescan, Inc.	1995	—
*	K984527	IN Touch Diabetes Management Software Summary page 1 …Chemistry Device Classification: Class II PREDICATE DEVICES · Health Buddy® with Buddylink (K993128) * In Touch Diabetes Management Software (K984527) · HomMed Central Station (K020184) DEVICE DESCRIPTION The Health Buddy appliance is a communications product that con…	Lifescan, Inc.	1999	1
*	K020184	Hommed Central Station Summary page 1 …Class II PREDICATE DEVICES · Health Buddy® with Buddylink (K993128) * In Touch Diabetes Management Software (K984527) · HomMed Central Station (K020184) DEVICE DESCRIPTION The Health Buddy appliance is a communications product that connects to a telephone line. It is used by…	Hommed, LLC	2002	—

Also cleared against K993128: 8 other devices →

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K042273	Modification to Health Buddy with Device Connectivity	Health Hero Network, Inc.	2004	45
K050567	Health Buddy Appliance	Health Hero Network, Inc.	2005	40
K060843	Modification to Health Buddy Appliance	Health Hero Network, Inc.	2006	39
K063612	Modification to Health Buddy Appliance	Health Hero Network, Inc.	2006	30
K042768	Medicompass Connect	Imetrikus, Inc.	2005	5
K090801	Electronic House Call	Express MD Solutions, LLC	2009	3
K070543	Modification to Health Buddy Appliance	Health Hero Network, Inc.	2007	2
K080091	Modification to:Health Buddy Appliance	Health Hero Network, Inc.	2008	1
K091021	Modification to Medicompass Connect	Imetrikus, Inc.	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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K042273 (Health Hero Network, Inc., 2004) has gone furthest, with 45 descendants of its own.
8 other devices also cite its predicate K993128.

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?

Health Buddy® with Buddylink is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040086 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040086: Health Buddy with Buddylink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040086

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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