510(k) · Cleared
ClearedDideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Biomedical, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Aug 12, 1996 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 12, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK961869 Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro…Sorin Biomedical, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK033987 D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
- Descendant · 2 generations on · 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
- Descendant · 2 generations on · 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
- Descendant · 3 generations on · 0 of its ownK242953 KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024
- Descendant · cites it directly · 0 of its ownK242092 MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024
Most influential descendants
Showing 5 of 5 · 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 · 2 generations on2descendants
- K072308D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen…Sorin Group Italia S.R.L. · 2007 · 2 generations on1descendant
- K242953KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024 · 3 generations on0descendants
- K242092MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K063255 | D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen… | Sorin Group Italia S.R.L. | 2007 | — |
| +2 | K072308 | D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen… | Sorin Group Italia S.R.L. | 2007 | — |
| +3 | K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | 2024 | — |
| +1 | K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2024 | 2 | 0 |
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 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
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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesDTM 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DTM
246in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTM
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTM
4in 2024
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 | — |
https://510kreport.com/device/K961869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961869: Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961869
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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