# K180843: HIgH-Flo Super26 Subcutaneous Needle Sets

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Med Systems, Inc. Dba Rms Medical Products
- Decided: Apr 4, 2019 after 367 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 no predicate by number.

Source page: https://510kreport.com/device/K180843
Methodology: https://510kreport.com/methodology