510(k) · Cleared

Cleared

Hanc Network

K952979510(k) TraditionalCleared Jul 25, 1996394-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

Healthtech Services Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jul 25, 1996 as substantially equivalent to K864318 (The Buddy Systems, Inc., 1987) and 4 other predicates after a 394-day review. Its family tree reaches back 1 generation to 1987. 128 later devices descend from it.

Decided: Jul 25, 1996
Review: 394 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K864318 (1987). 5 ancestors in all. 128 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
This deviceK952979 Hanc NetworkHealthtech Services Corp. · 1996
Descendant · cites it directly · 123 of its ownK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
Descendant · 2 generations on · 103 of its ownK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
Descendant · 3 generations on · 98 of its ownK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
Descendant · 3 generations on · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003
Descendant · cites it directly · 88 of its ownK030419 Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 2003 · Recalled

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

1997high 15 (2009) · low 0 (1998)2026

Most influential descendants

Showing 5 of 128 · See all

K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997 · cites it directly123descendants
K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999 · 2 generations on103descendants
K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems · 2002 · 3 generations on98descendants
K031840Carematix Wellness SystemCarematix, Inc. · 2003 · 3 generations on90descendants
K030419Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 2003 · cites it directly88descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864318	The Buddy System/Health Information System	The Buddy Systems, Inc.	1987	—
0 (this device)	K952979	Hanc Network	Healthtech Services Corp.	1996	—
+1	K964408	Poseidon Cardiac Monitoring System (PCMS)	Instromedix, Inc.	1997	—
+2	K993169	Modification of: Physiological Signal Transmitter and Receiver, Model 3810A	Hewlett-Packard Co.	1999	—
+3	K023749	The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)	Philips Medical Systems	2002	—
+3	K031840	Carematix Wellness System	Carematix, Inc.	2003	—
+1	K030419	Viterion 100 Telehealth Monitor	Viterion Telehealthcare, LLC	2003	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1988	1	0
1993	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	3	0
2002	1	0
2003	2	0
2004	6	0
2005	5	0
2006	11	0
2007	5	0
2008	7	0
2009	15	0
2010	11	0
2011	11	0
2012	6	0
2013	13	0
2014	6	0
2015	2	0
2016	1	0
2017	5	0
2018	3	0
2020	3	0
2022	3	0
2023	1	0
2024	1	0
2025	5	0
2026	1	0

FIG. 1 — Lineage of K952979, 1987–2026Source: 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? (6)

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
*	K864318	The Buddy System/Health Information System Summary page 3 …ve, Suite A » Northbrook, IL 60062 708.205.2530 » 708.205.1970 fax HealthTech - Predicate Devices: ) ) Overall Predicate The Buddy System 510(k) #: K864318 Vital Sign Component Predicates Blood Pressure Nellcor Symphony™ N-3100 BP Monitor K945947 ECG BCI 9100 Multigas Monitor K92138…	The Buddy Systems, Inc.	1987	—
*	K945947	Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor… Summary page 3 …h - Predicate Devices: ) ) Overall Predicate The Buddy System 510(k) #: K864318 Vital Sign Component Predicates Blood Pressure Nellcor Symphony™ N-3100 BP Monitor K945947 ECG BCI 9100 Multigas Monitor K921388/B ECG electrodes ' NDM Tracets 3000 K875015 Temperature BCI 9100 Multigas Monitor K921388/B…	Nellcor, Inc.	1995	—
*	K921388	Biochem 9100 Multigas Monitor Ibp Module Summary page 3 …Predicate The Buddy System 510(k) #: K864318 Vital Sign Component Predicates Blood Pressure Nellcor Symphony™ N-3100 BP Monitor K945947 ECG BCI 9100 Multigas Monitor K921388/B ECG electrodes ' NDM Tracets 3000 K875015 Temperature BCI 9100 Multigas Monitor K921388/B Temperature Probe _ Criticon Dinamap™…	Biochem International, Inc.	1993	—
*	K875015	Tracets 3000 Summary page 3 …18 Vital Sign Component Predicates Blood Pressure Nellcor Symphony™ N-3100 BP Monitor K945947 ECG BCI 9100 Multigas Monitor K921388/B ECG electrodes ' NDM Tracets 3000 K875015 Temperature BCI 9100 Multigas Monitor K921388/B Temperature Probe _ Criticon Dinamap™ 8100T Vital Signs Monitor K874378 Pulse Ox…	Lectec Corp.	1988	—
*	K874378	Dinamap Vital Signs Monitor, Model 8100T Summary page 3 …itor K921388/B ECG electrodes ' NDM Tracets 3000 K875015 Temperature BCI 9100 Multigas Monitor K921388/B Temperature Probe _ Criticon Dinamap™ 8100T Vital Signs Monitor K874378 Pulse Oximetry BCI 9100 Multigas Monitor K921388/B Electronic Stethoscope Andries Tek Electronic Stethoscope Pre-1976 Device Inte…	Critikon Company, LLC	1987	—
*	—	Andries Tek Electronic Stethoscope Named without a submission number			—

Also cleared against K864318: 1 other device →

What descends from it? (128)

See all 128

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

Number	Device	Applicant	Decided	Descendants
K964408	Poseidon Cardiac Monitoring System (PCMS)	Instromedix, Inc.	1997	123
K030419	Viterion 100 Telehealth Monitor	Viterion Telehealthcare, LLC	2003	88
K040012	Well@Home System	Zoe Medical, Inc.	2004	1

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?

None of the 5 ancestors has a recall.
Of its descendants, K964408 (Instromedix, Inc., 1997) has gone furthest, with 123 descendants of its own.
1 other device also cites its predicate K864318.

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 HANC™ Network is intended to be used as a clinical tool to provide a method of monitoring a patient's health status at home and a method for transferring the data to a nurse for review. The HANC™ Network is indicated for use for patients that require medical observation and monitoring while at home, who have medication or therapy compliance issues, and who need training reinforcement. The HANC™ Network is not a patient emergency response system. It does not analyze patient information and does not offer medical advice to the patient. It collects, stores, and transmits patient information to the health professional.

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/K952979 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952979: Hanc Network.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952979

Report an extraction error

Are you the manufacturer?

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