510(k) · Cleared

Cleared

Diasys Integra II

K042109510(k) TraditionalCleared Mar 9, 2005216-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

Novacor France · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 9, 2005 as substantially equivalent to K003004 (Suntech Medical Instruments, Inc., 2000) and 1 other predicate after a 216-day review. Its family tree reaches back 1 generation to 1989.

Decided: Mar 9, 2005
Review: 216 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K881771 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881771 Sensocor (TM) DiasysSensormedix, Inc. · 1989
This deviceK042109 Diasys Integra IINovacor France · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881771	Sensocor (TM) Diasys	Sensormedix, Inc.	1989	—
0 (this device)	K042109	Diasys Integra II	Novacor France	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K042109, 1989–2005Source: 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

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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
*	K003004	Oscar 2, Model 222 Summary page 1 …e: Ambulatory blood pressure recorder Classification name :Blood Pressure Measurement System Predicate devices OSCAR 2 - Model 222 - SUNTECIH MEDICAL fNTRUMENTS Inc. - K003004. SENSOCOR TM DIASYS - SENSORMEDIX Inc. - K881771 Device description The DIASYS INTEGRA 1I is a non invasive automatic ambulatory…	Suntech Medical Instruments, Inc.	2000	—
*	K881771	Sensocor (TM) Diasys Summary page 1 …tion name :Blood Pressure Measurement System Predicate devices OSCAR 2 - Model 222 - SUNTECIH MEDICAL fNTRUMENTS Inc. - K003004. SENSOCOR TM DIASYS - SENSORMEDIX Inc. - K881771 Device description The DIASYS INTEGRA 1I is a non invasive automatic ambulatory blood pressure recorder. It has two standard mod…	Sensormedix, Inc.	1989	—

Also cleared against K003004: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
6 other devices also cite its predicate K003004.

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 Diasys Integra Il is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode.

The procedure can be:

* transfert to a computer for further analysis and report printing using the DiasySoft software

* printed out directly in a report form by a printer connected to the unit

* transfert to a remote computer through a modem connected to the unit

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042109 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042109: Diasys Integra II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042109

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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