510(k) · Cleared
ClearedD731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 PH.I.SI.O Pediatric Arterial Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.R.L. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on May 20, 2005 as substantially equivalent to K002493 (Cobe Cardiovascular, Inc., 2000) after a 7-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 20, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002493 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002493 Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in…Cobe Cardiovascular, Inc. · 2000
- This deviceK051232 D731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40…Dideco S.R.L. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002493 | Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation)… | Cobe Cardiovascular, Inc. | 2000 | — |
| 0 (this device) | K051232 | D731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 PH.I.SI.O… | Dideco S.R.L. | 2005 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002493 | Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation)…Summary page 2…lter with 40 micron screen with biocompatible treatment surface (K002493) (hereafter referred to as D736 MICRO Ph.I.S.I.O.… | 2000 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K002493.
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 D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with phosphoryicholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O., with 40 micron screen with phosphoryicholine coating 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/K051232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051232: D731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 PH.I.SI.O Pediatric 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/K051232
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