510(k) · Cleared
ClearedArterial Blood Filter, #AF-1025
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bentley Laboratories, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Jun 29, 1982 after a 173-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jun 29, 1982
- Review
- 173 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK820044 Arterial Blood Filter, #AF-1025Bentley Laboratories, Inc. · 1982
- Descendant · cites it directly · 3 of its ownK022071 Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra…Embol-X, Inc. · 2003 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK031946 Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large…Edwards Lifesciences, LLC · 2003
- Descendant · 2 generations on · 1 of its ownK141465 Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK182302 CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019
Class I recalls in this family
- K022071 Embol-X Aortic…cites it directly · 2003
Most influential descendants
Showing 4 of 4 · See all- K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models…Embol-X, Inc. · 2003 · cites it directly3descendants
- K031946Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-LargeEdwards Lifesciences, LLC · 2003 · cites it directly2descendants
- K141465Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015 · 2 generations on1descendant
- K182302CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820044 | Arterial Blood Filter, #AF-1025 | Bentley Laboratories, Inc. | 1982 | — |
| +1 | K022071 | Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models… | Embol-X, Inc. | 2003 | Class I |
| +1 | K031946 | Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large | Edwards Lifesciences, LLC | 2003 | — |
| +2 | K141465 | Cardiogard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2015 | — |
| +3 | K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 1 |
| 2015 | 1 | 0 |
| 2019 | 1 | 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.
1 device in this family has a Class I recall. 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000Embol-X, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K022071 (Embol-X, Inc., 2003) has gone furthest, with 3 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/K820044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K820044: Arterial Blood Filter, #AF-1025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K820044
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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