510(k) · Cleared
ClearedKIDS Arterial Filters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Dec 20, 2024 as substantially equivalent to K063255 (Sorin Group Italia S.R.L., 2007) and 1 other predicate after an 86-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Dec 20, 2024
- Review
- 86 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961869 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK961869 Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro…Sorin Biomedical, Inc. · 1996
- 3 generations backK033987 D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
- 2 generations backK063255 D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron…Sorin Group Italia S.R.L. · 2007
- 1 generation backK072308 D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron…Sorin Group Italia S.R.L. · 2007
- This deviceK242953 KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961869 | Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40 | Sorin Biomedical, Inc. | 1996 | — |
| −3 | 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 | — |
| −1 | K072308 | D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen… | Sorin Group Italia S.R.L. | 2007 | — |
| 0 (this device) | K242953 | KIDS 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 |
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 |
|---|---|---|---|
| * | K063255 | D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen…Summary page 6…d and unmodified models have the same fundamental scientific technology and intended use: 510(k) Number: K063255 Device Trade Name: D130 PH.I.S.I.O DIDECO KIDS… | 2007 |
| * | K072308 | D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen…Summary page 6…cation: Class II Classification Panel: Cardiovascular 510(k) Number: K072308 Device Trade Name: D131 PH.I.S.I.O DIDECO KIDS… | 2007 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K063255.
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. 2024, this device’s year, is highlighted.
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 device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.
The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242953: KIDS Arterial Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242953
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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