510(k) Report

510(k) · Cleared

Cleared

Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter

K002493510(k) TraditionalCleared Nov 30, 2000108-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 Nov 30, 2000 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Nov 30, 2000
Review
108 days
Class
Class II
Product code
DTM
Recalls
None
Predicates
0

7 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2007: 2 descendants cleared2004: 1 descendant cleared2024: 2 descendants cleared200020052010201520202025
  1. This deviceK002493 Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in…Cobe Cardiovascular, Inc. · 2000
  2. Descendant · cites it directly · 4 of its ownK033987 D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
  3. Descendant · cites it directly · 2 of its ownK063255 D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron…Sorin Group Italia S.R.L. · 2007
  4. Descendant · cites it directly · 1 of its ownK072308 D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron…Sorin Group Italia S.R.L. · 2007
  5. Descendant · 2 generations on · 0 of its ownK242953 KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024
  6. Descendant · 2 generations on · 0 of its ownK242092 MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22007: 22024: 2
2004high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K033987D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004 · cites it directly4descendants
  • K063255D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L. · 2007 · cites it directly2descendants
  • K072308D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L. · 2007 · cites it directly1descendant
  • K242953KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024 · 2 generations on0descendants
  • K242092MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002493Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation)…Cobe Cardiovascular, Inc.2000—
+1K033987D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A.2004—
+1K063255D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L.2007—
+1K072308D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L.2007—
+2K242953KIDS Arterial FiltersSorin Group Italia S.R.L.2024—
+2K242092MICRO Arterial FiltersSorin Group Italia S.R.L.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200720
202420
FIG. 1 — Lineage of K002493, 2000–2024Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K033987D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A.20044
K063255D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L.20072
K072308D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L.20071
K052717D732 Micro 27 PH.I.S.I.O. Adult Arterial FilterDideco S.R.L.20050
K051232D731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 PH.I.SI.O Pediatric…Dideco S.R.L.20050

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, K033987 (Dideco S.P.A., 2004) has gone furthest, with 4 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—

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
  • K040184Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe 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

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/K002493 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002493: Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002493

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026