# K781744: IV Set with Graduated Chamber

- Pathway: 510(k) (Traditional)
- Applicant: National Patent Development Corp.
- Decided: Dec 7, 1978 after 48 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 9 (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
- Oct 29, 2025 · Class II · Z-0621-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0622-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Aug 10, 2021 · Class II · Z-2549-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2547-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Jun 30, 2008 · Not classified · Z-2410-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2414-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2411-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2413-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2412-2008: incorrect burette was packaged with the product

Source page: https://510kreport.com/device/K781744
Methodology: https://510kreport.com/methodology