# K852140: Namic Contrast & Fluid Delivery Spikes (Various)

- Pathway: 510(k) (Traditional)
- Applicant: North American Instrument Corp.
- Decided: May 30, 1985 after 14 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (1 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.
1 of 1 device 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.

## Recalls of this device
- Dec 16, 2024 · Class I · Z-0764-2025: Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the
- Mar 12, 2024 · Class II · Z-1807-2024: Products have a lack of sterility assurance.
- Jan 13, 2017 · Class II · Z-1853-2017: The product has the potential to be non-sterile as it was not packaged in accordance to specification.

Source page: https://510kreport.com/device/K852140
Methodology: https://510kreport.com/methodology