510(k) · Cleared

Cleared

Lifeclinic, Model 2400

K040562510(k) SpecialCleared Aug 31, 2004181-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

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

Cleared on Aug 31, 2004 as substantially equivalent to K850893 (Sun Dance Technology, Inc., 1985) after a 181-day review. Its family tree reaches back 1 generation to 1985. 8 later devices descend from it.

Decided: Aug 31, 2004
Review: 181 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K850893 (1985). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK850893 BP/Clinic Sys Measurement, BP Non-InvasiveSun Dance Technology, Inc. · 1985
This deviceK040562 Lifeclinic, Model 2400Lifeclinic International, Inc. · 2004
Descendant · cites it directly · 5 of its ownK063137 Pharmasmart Public Use Blood Pressure Monitor, Models…Pharmasmart, Inc. · 2007
Descendant · cites it directly · 4 of its ownK063008 Health Check KioskXperex Corporation · 2007
Descendant · cites it directly · 3 of its ownK093389 Csi Model 5K Managed Health System KioskComputerized Screening, Inc. · 2009
Descendant · 2 generations on · 1 of its ownK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
Descendant · 3 generations on · 0 of its ownK153600 Consult Station TSH4D Sas · 2017

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all

K063137Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000Pharmasmart, Inc. · 2007 · cites it directly5descendants
K063008Health Check KioskXperex Corporation · 2007 · cites it directly4descendants
K093389Csi Model 5K Managed Health System KioskComputerized Screening, Inc. · 2009 · cites it directly3descendants
K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010 · 2 generations on1descendant
K153600Consult Station TSH4D Sas · 2017 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850893	BP/Clinic Sys Measurement, BP Non-Invasive	Sun Dance Technology, Inc.	1985	—
0 (this device)	K040562	Lifeclinic, Model 2400	Lifeclinic International, Inc.	2004	—
+1	K063137	Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000	Pharmasmart, Inc.	2007	—
+1	K063008	Health Check Kiosk	Xperex Corporation	2007	—
+1	K093389	Csi Model 5K Managed Health System Kiosk	Computerized Screening, Inc.	2009	—
+2	K101198	Csi Managed Health System Model: Csi Model 9K	Computerized Screening, Inc.	2010	—
+3	K153600	Consult Station TS	H4D Sas	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	1	0
2010	1	0
2012	1	0
2015	2	0
2017	1	0

FIG. 1 — Lineage of K040562, 1985–2017Source: 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? (1)

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
*	K850893	BP/Clinic Sys Measurement, BP Non-Invasive Summary page 1 …ssification Name: System, measurement, blood pressure, non-invasive, systolic and/or diastolic, 74J0E, 870.1130 (3) Equivalent legally-marketed devices: K850893, "BP/Clinic" (4) Description The Lifeclinic 2400 is an automated system for measuring blood pressure and pulse rate des…	Sun Dance Technology, Inc.	1985	—

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K063137	Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000	Pharmasmart, Inc.	2007	5
K063008	Health Check Kiosk	Xperex Corporation	2007	4
K093389	Csi Model 5K Managed Health System Kiosk	Computerized Screening, Inc.	2009	3
K113402	Solohealth Station	Solohealth, Inc.	2012	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?

Its one ancestor has no recall.
Of its descendants, K063137 (Pharmasmart, Inc., 2007) has gone furthest, with 5 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	—

What is it indicated for?

The Lifeclinic LC500 is indicated for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040562 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040562: Lifeclinic, Model 2400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040562

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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