# K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter

- Pathway: 510(k) (Special)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Feb 26, 2004 after 31 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dideco Micro 40 Adult Arterial Filter: named in the summary without a submission number

## Most influential descendants
- K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir (2012), 10 descendants of its own
- K180448: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (2018), 5 descendants of its own
- K122844: Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (2012), 3 descendants of its own
- K130433: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate (2013), 2 descendants of its own
- K261438: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (2026), 0 descendants of its own

## Indications for use
The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

Source page: https://510kreport.com/device/K040184
Methodology: https://510kreport.com/methodology