510(k) · Cleared
ClearedD735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.P.A. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Jan 8, 2004 as substantially equivalent to K961869 (Sorin Biomedical, Inc., 1996) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Jan 8, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961869 (1996). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961869 Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro…Sorin Biomedical, Inc. · 1996
- This deviceK033987 D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
- 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
- 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
- Descendant · 2 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 4 of 4 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961869 | Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40 | Sorin Biomedical, Inc. | 1996 | — |
| 0 (this device) | K033987 | D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters | Dideco S.P.A. | 2004 | — |
| +1 | K063255 | D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen… | Sorin Group Italia S.R.L. | 2007 | — |
| +1 | K072308 | D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen… | Sorin Group Italia S.R.L. | 2007 | — |
| +2 | K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | 2024 | — |
| +1 | K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2024 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K961869 | Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40Summary page 1…ith 40 micron screen (hereafter referred to as D735 and D736 respectively) (K961869), and modified for the D736 MICRO 40 Ph.I.S.I.O.: Dideco Newborn-Infant Arterial F… | 1996 |
| * | K002493 | Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation)…Summary page 1…Filter with Ph.I.S.I.O. coating (Phosphorilcholine coating) as described in K002493. DEVICE DESCRIPTION: The D735 MICRO 20 and D736 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial l… | 2000 |
What descends from it? (4)
3 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?
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 | — |
What is it indicated for?
The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen are recommended for use in 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 maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033987 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033987: D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033987
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