510(k) · Cleared

Cleared

March Healthcare Health Monitoring Kit

K060194510(k) TraditionalCleared Feb 13, 200619-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

March Healthcare Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Feb 13, 2006 as substantially equivalent to K951193 (Tycos Instruments, Inc., 1996) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.

Decided: Feb 13, 2006
Review: 19 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951193 (1996). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
This deviceK060194 March Healthcare Health Monitoring KitMarch Healthcare Corporation · 2006
Descendant · cites it directly · 3 of its ownK090801 Electronic House CallExpress MD Solutions, LLC · 2009
Descendant · 2 generations on · 1 of its ownK102063 Health-E-Connect SystemAlr Technologies · 2011
Descendant · 3 generations on · 0 of its ownK163664 Health-e-Connect System with IDAAlr Technologies · 2017
Descendant · 2 generations on · 0 of its ownK093895 Ally Platform SystemContinuity Health Solutions · 2010
Descendant · cites it directly · 0 of its ownK062338 TelevisitPHD Medical · 2006

Most influential descendants

Showing 5 of 5 · See all

K090801Electronic House CallExpress MD Solutions, LLC · 2009 · cites it directly3descendants
K102063Health-E-Connect SystemAlr Technologies · 2011 · 2 generations on1descendant
K163664Health-e-Connect System with IDAAlr Technologies · 2017 · 3 generations on0descendants
K093895Ally Platform SystemContinuity Health Solutions · 2010 · 2 generations on0descendants
K062338TelevisitPHD Medical · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951193	Clinical Vital Signs Monitor, Model #52STP-E1	Tycos Instruments, Inc.	1996	—
0 (this device)	K060194	March Healthcare Health Monitoring Kit	March Healthcare Corporation	2006	—
+1	K090801	Electronic House Call	Express MD Solutions, LLC	2009	—
+2	K102063	Health-E-Connect System	Alr Technologies	2011	—
+3	K163664	Health-e-Connect System with IDA	Alr Technologies	2017	—
+2	K093895	Ally Platform System	Continuity Health Solutions	2010	—
+1	K062338	Televisit	PHD Medical	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2010	1	0
2011	1	0
2017	1	0

FIG. 1 — Lineage of K060194, 1996–2017Source: 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? (2)

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
*	K951193	Clinical Vital Signs Monitor, Model #52STP-E1 Summary page 1 …~~~~~PRODUCT CODE NUMBER CLINICAL VITIAL Wel~ch Allyn Inc I Class lI/DXN K95 1193) SIGNS MONITOR- MOI)EL. #52S P'l-El (52-000) I L-Scope Electronic…	Tycos Instruments, Inc.	1996	—
*	K961301	E-Scope Electronic Stethoscope Model 718-7120 Summary page 4 …use Nonin OEM pulse oximetry technology. • The headt and lung sound specifications and performance are derived from the Cardionies stethoscope (K961301). The networked electronic stethoscope is an added feature on the HMK that is not available on the Welch Allyn 52000.…	Delphi Consulting Group	1996	—

Also cleared against K951193: 5 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K090801	Electronic House Call	Express MD Solutions, LLC	2009	3
K062338	Televisit	PHD Medical	2006	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?

None of the 2 ancestors has a recall.
Of its descendants, K090801 (Express MD Solutions, LLC, 2009) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K951193.

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 Health Monitoring Kit (HMK) is a non-invasive, spot-measuring device used to measure blood pressure, heart rate, oxygen saturation levels, pulse rate, and heart and lung sounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060194 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060194: March Healthcare Health Monitoring Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060194

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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