510(k) Report

510(k) · Cleared

Cleared

Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter

K040184510(k) SpecialCleared Feb 26, 200431-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

Cobe Cardiovascular, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Feb 26, 2004 after a 31-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided
Feb 26, 2004
Review
31 days
Class
Class II
Product code
DTM
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2024: 2 descendants cleared2013: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants cleared2025: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK040184 Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe Cardiovascular, Inc. · 2004
  2. Descendant · cites it directly · 10 of its ownK121536 Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell…Sorin Group Italia S.R.L. · 2012
  3. Descendant · 2 generations on · 5 of its ownK180448 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber…Sorin Group Italia S.R.L. · 2018
  4. Descendant · 2 generations on · 3 of its ownK122844 Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial…Sorin Group Italia S.R.L. · 2012
  5. Descendant · 2 generations on · 2 of its ownK130433 Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2013 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK261438 HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2012: 22013: 12018: 12020: 22022: 12024: 22025: 22026: 1
2012high 2 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 12 · See all
  • K121536Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirSorin Group Italia S.R.L. · 2012 · cites it directly10descendants
  • K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2018 · 2 generations on5descendants
  • K122844Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L. · 2012 · 2 generations on3descendants
  • K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L. · 2013 · 2 generations on2descendants
  • K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040184Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe Cardiovascular, Inc.2004—
+1K121536Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirSorin Group Italia S.R.L.2012—
+2K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with…Sorin Group Italia S.R.L.2018—
+2K122844Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and…Sorin Group Italia S.R.L.2012—
+2K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire…Sorin Group Italia S.R.L.20131
+3K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201310
201810
202020
202210
202420
202520
202610
FIG. 1 — Lineage of K040184, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—Dideco Micro 40 Adult Arterial Filter
Named without a submission number
—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K121536Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirSorin Group Italia S.R.L.201210
K242092MICRO Arterial FiltersSorin Group Italia S.R.L.20240

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?

  • Of its descendants, K121536 (Sorin Group Italia S.R.L., 2012) has gone furthest, with 10 descendants of its own.

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.

FDA decisions per year · DTM

2in 2024

2007: 32008: 12009: 52010: 22011: 12012: 22013: 12023: 12024: 22026 (partial year): 1
2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007: 60 days median2009: 246 days median
2007high 246 (2009) · low 60 (2007)2026

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

Recalls per year · DTM

1in 2019

2008: 12019: 1
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

2007: 82008: 22010: 32011: 82012: 62013: 92014: 642015: 342016: 272017: 152018: 232019: 52020: 12021: 12022: 42024: 4
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200736008
20081—12
2009524600
20102—03
20111—08
20122—06
20131—09
20140—064
20150—034
20160—027
20170—015
20180—023
20190—15
20200—01
20210—01
20220—04
20231—00
20242—04
20250—00
20261—0—

What is it indicated for?

The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

Indications for use as stated in the FDA summary.

More from Cobe Cardiovascular, Inc.

43 FDA decisions under this applicant name. See the company

  • K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
  • K042473Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004
  • K033641Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800Cobe Cardiovascular, Inc. · 2003
  • K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 20031 recall
  • K021830Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemCobe Cardiovascular, Inc. · 2002

Recent decisions in DTM

The DTM category page

  • K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronic · 2026
  • K242953KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024
  • K242092MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024
  • K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc. · 2023
  • K123351Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceMedtronic Perfusion Systems · 2013

https://510kreport.com/device/K040184 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040184

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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