# K811933: Guardian, Volumetric Control Delivery

- Pathway: 510(k) (Traditional)
- Applicant: Avi, Inc.
- Decided: Jul 20, 1981 after 14 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 32 (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 8, 2005 · Not classified · Z-0658-06: Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- Dec 8, 2005 · Not classified · Z-0659-06: Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- Dec 8, 2005 · Not classified · Z-0660-06: Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- 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/K811933
Methodology: https://510kreport.com/methodology