510(k) · Cleared
ClearedAF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. 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 Jan 22, 2010 after a 29-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jan 22, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK093986 AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. Arterial FiltersSorin Group Italia S.R.L. · 2010
- Descendant · cites it directly · 10 of its ownK112525 D731 Micro 27 PH.I.S.I.O. and D733 Micro 40 PH.I.S.O. Arterial FiltersParexel International · 2011
- Descendant · 2 generations on · 8 of its ownK120185 Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter…Sorin Group Italia S.R.L. · 2012
- Descendant · 3 generations on · 5 of its ownK180448 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber…Sorin Group Italia S.R.L. · 2018
- Descendant · 3 generations on · 0 of its ownK261438 HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026
- Descendant · 3 generations on · 0 of its ownK250821 Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and…Eurosets S.R.L · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K112525D731 Micro 27 PH.I.S.I.O. and D733 Micro 40 PH.I.S.O. Arterial FiltersParexel International · 2011 · cites it directly10descendants
- K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L. · 2012 · 2 generations on8descendants
- K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2018 · 3 generations on5descendants
- K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026 · 3 generations on0descendants
- K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093986 | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. Arterial Filters | Sorin Group Italia S.R.L. | 2010 | — |
| +1 | K112525 | D731 Micro 27 PH.I.S.I.O. and D733 Micro 40 PH.I.S.O. Arterial Filters | Parexel International | 2011 | — |
| +2 | K120185 | Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and… | Sorin Group Italia S.R.L. | 2012 | — |
| +3 | K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with… | Sorin Group Italia S.R.L. | 2018 | — |
| +3 | K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | 2026 | — |
| +3 | K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon… | Eurosets S.R.L | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | D731 MICRO Ph.I.S.I.O. Named without a submission number | |
| * | — | D733 MICRO Ph.I.S.I.O. Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112525 | D731 Micro 27 PH.I.S.I.O. and D733 Micro 40 PH.I.S.O. Arterial Filters | 2011 | 10 |
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, K112525 (Parexel International, 2011) has gone furthest, with 10 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. 2010, 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 AF 620 Ph.I.S.I.O. with 20 micron screen with phosphorylcholine coating and the AF 640 Ph.I.S.I.O. with 40 micron screen with phosphorylcholine 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 may be 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/K093986 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093986: AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. Arterial Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093986
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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