# K931173: Primary Admin Set W/Univ SP-Man Below/Abv Pump CH

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Apr 15, 1994 after 403 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962801: Safe Mate I.V. Extension Sets (1996), 0 descendants of its own
- K962802: Safe Mate I.V. Fluid Delivery Sets (1996), 0 descendants of its own

## Recalls of this device
- Aug 2, 2021 · Class II · Z-2463-2021: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy 
- Mar 5, 2019 · Class II · Z-1121-2019: The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
- Mar 5, 2019 · Class II · Z-1120-2019: The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Source page: https://510kreport.com/device/K931173
Methodology: https://510kreport.com/methodology