510(k) · Cleared

Cleared

Apm Blood Pressure Monitor, Model BP108A

K040159510(k) AbbreviatedCleared Mar 22, 200459-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

Asia Pacific Microsystems, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 22, 2004 as substantially equivalent to K021239 (Eikon Healthcare Device Corp., 2002) after a 59-day review. Its family tree reaches back 1 generation to 2002. 17 later devices descend from it.

Decided: Mar 22, 2004
Review: 59 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K021239 (2002). 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK021239 Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002
This deviceK040159 Apm Blood Pressure Monitor, Model BP108AAsia Pacific Microsystems, Inc. · 2004
Descendant · cites it directly · 8 of its ownK051703 Clever TD-3018A Blood Pressure MonitorTaidoc Technology Corporation · 2005
Descendant · cites it directly · 6 of its ownK042795 Clever Chek TD-3213Taidoc Technology Corporation · 2005
Descendant · 2 generations on · 4 of its ownK051907 InnocorInnovision A/S · 2006
Descendant · 3 generations on · 3 of its ownK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
Descendant · 3 generations on · 2 of its ownK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2005high 3 (2005) · low 0 (2012)2026

Most influential descendants

Showing 5 of 17 · See all

K051703Clever TD-3018A Blood Pressure MonitorTaidoc Technology Corporation · 2005 · cites it directly8descendants
K042795Clever Chek TD-3213Taidoc Technology Corporation · 2005 · cites it directly6descendants
K051907InnocorInnovision A/S · 2006 · 2 generations on4descendants
K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007 · 3 generations on3descendants
K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S · 2009 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021239	Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M	Eikon Healthcare Device Corp.	2002	—
0 (this device)	K040159	Apm Blood Pressure Monitor, Model BP108A	Asia Pacific Microsystems, Inc.	2004	—
+1	K051703	Clever TD-3018A Blood Pressure Monitor	Taidoc Technology Corporation	2005	—
+1	K042795	Clever Chek TD-3213	Taidoc Technology Corporation	2005	—
+2	K051907	Innocor	Innovision A/S	2006	—
+3	K071911	Cardiopulmonary Exercise Testing Option to Innocor	Innovision A/S	2007	—
+3	K083879	Innocor Ergospirometry System (INN00010), the Basic Innocor Including…	Innovision A/S	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2006	3	0
2007	2	0
2008	2	0
2009	3	0
2010	1	0
2011	2	0
2020	1	0

FIG. 1 — Lineage of K040159, 2002–2020Source: 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
*	K021239	Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M Summary page 5 …ectronic or Automated Sphygmomanometers Legally marketed device for substantial equivalence comparison: Eikon Automatic Digital Blood Pressure Monitor, HD-400M (K021239) Summary for substantial equivalence comparison:…	Eikon Healthcare Device Corp.	2002	—

Also cleared against K021239: 1 other device →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K051703	Clever TD-3018A Blood Pressure Monitor	Taidoc Technology Corporation	2005	8
K042795	Clever Chek TD-3213	Taidoc Technology Corporation	2005	6
K052671	Hoca EZ-Care BP108, Tender-Care BP109	Hoca Medical Microsystem, Inc.	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?

Its one ancestor has no recall.
Of its descendants, K051703 (Taidoc Technology Corporation, 2005) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K021239.

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 device as a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25”-7.75".

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/K040159 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040159: Apm Blood Pressure Monitor, Model BP108A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040159

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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