# K961251: Punctur-Guard Winged Set

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Plexus, Inc.
- Decided: Jun 27, 1996 after 87 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Vacutainer® Brand Blood Collection Set: named in the summary without a submission number
- (no number) SurFlo® Winged Infusion Set: named in the summary without a submission number
- (no number) Butterfly® Infusion Set: named in the summary without a submission number

Source page: https://510kreport.com/device/K961251
Methodology: https://510kreport.com/methodology