510(k) · Cleared

Cleared

MICRO Arterial Filters

K242092510(k) SpecialCleared Nov 18, 2024124-day reviewClass II21 CFR 870.4260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sorin Group Italia S.R.L. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Nov 18, 2024 as substantially equivalent to K952270 (Sorin Biomedical, Inc., 1995) and 5 other predicates after a 124-day review. Its family tree reaches back 2 generations to 1996.

Decided: Nov 18, 2024
Review: 124 days
Class: Class II
Product code: DTM
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K961869 (1996). 9 ancestors in all, the oldest K945198 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961869 Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro…Sorin Biomedical, Inc. · 1996
1 generation backK033987 D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
This deviceK242092 MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961869	Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40	Sorin Biomedical, Inc.	1996	—
−1	K033987	D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters	Dideco S.P.A.	2004	—
0 (this device)	K242092	MICRO Arterial Filters	Sorin Group Italia S.R.L.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
2000	1	0
2004	2	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K242092, 1996–2024Source: 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 DTM? 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 DTM device

#1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 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
*	K952270	Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen Summary page 6 …ces. Both modified and unmodified models have the same fundamental scientific technology and intended use: 510(k) Number: K952270 K040184 Device Trade DIDECO ADULT DIDECO MICRO 40…	Sorin Biomedical, Inc.	1995	—
*	K040184	Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter Summary page 6 …tion Panel: Cardiovascular Special 510(k) – MICRO Arterial Filters CONFIDENTIALPage 1 III. Predicate Device Primary Predicate: K040184 The MICRO Arterial Filters are substantially equivalent to the following cleared predicate devices. Both mo…	Cobe Cardiovascular, Inc.	2004	—
*	K041061	D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters Summary page 6 …Classification Cardiovascular Cardiovascular Panel: 510(k) Number: K041061 K112525 Device Trade D731 MICRO 20 AND D731 MICRO 27…	Dideco S.P.A.	2004	—
*	K112525	D731 Micro 27 PH.I.S.I.O. and D733 Micro 40 PH.I.S.O. Arterial Filters Summary page 6 …sification Cardiovascular Cardiovascular Panel: 510(k) Number: K041061 K112525 Device Trade D731 MICRO 20 AND D731 MICRO 27 Name…	Parexel International	2011	—
*	K961869	Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40 Summary page 6 …Classification Cardiovascular Cardiovascular Panel: 510(k) Number: K961869 K033987 Device Trade DIDECO D735 MICRO 20 AND…	Sorin Biomedical, Inc.	1996	—
*	K033987	D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters Summary page 6 …sification Cardiovascular Cardiovascular Panel: 510(k) Number: K961869 K033987 Device Trade DIDECO D735 MICRO 20 AND Name:…	Dideco S.P.A.	2004	—

Also cleared against K952270: 2 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?

The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 20.9 years on median.
None of the 9 ancestors has a recall.
2 other devices also cite its predicate K952270.

How does its category compare?

All DTM devices

DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · DTM

2in 2024

2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007high 246 (2009) · low 60 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTM

1in 2019

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTM

4in 2024

2007high 64 (2014) · low 0 (2009)2025

MAUDE reports naming product code DTM, 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	3	60	0	8
2008	1	—	1	2
2009	5	246	0	0
2010	2	—	0	3
2011	1	—	0	8
2012	2	—	0	6
2013	1	—	0	9
2014	0	—	0	64
2015	0	—	0	34
2016	0	—	0	27
2017	0	—	0	15
2018	0	—	0	23
2019	0	—	1	5
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	4
2023	1	—	0	0
2024	2	—	0	4
2025	0	—	0	0
2026	1	—	0	—

What is it indicated for?

The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K242092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242092: MICRO Arterial Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242092

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