# K781978: Puncture Kit, Disposalbe Vein

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Dec 12, 1978 after 15 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (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
- Apr 21, 2026 · Class I · Z-2396-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect

Source page: https://510kreport.com/device/K781978
Methodology: https://510kreport.com/methodology