# K896161: Avi Model 2012, 1.2 Micron Filter IV Administra.

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jan 11, 1990 after 79 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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.

## Recalls of this device
- Dec 3, 2004 · Not classified · Z-0465-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0466-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0464-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0468-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0469-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0472-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0474-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0467-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0470-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0471-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0479-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0473-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0484-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0485-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0475-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0476-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0477-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0478-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0480-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0481-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0482-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0486-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0487-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0483-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0489-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0490-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0491-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0492-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 
- Dec 3, 2004 · Not classified · Z-0488-05: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close 

Source page: https://510kreport.com/device/K896161
Methodology: https://510kreport.com/methodology