# K820044: Arterial Blood Filter, #AF-1025

- Pathway: 510(k) (Traditional)
- Applicant: Bentley Laboratories, Inc.
- Decided: Jun 29, 1982 after 173 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000 (2003), 3 descendants of its own
- K031946: Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large (2003), 2 descendants of its own
- K141465: Cardiogard Emboli Protection Cannula (2015), 1 descendant of its own
- K182302: CardioGard Emboli Protection Cannula (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K820044
Methodology: https://510kreport.com/methodology