# K021080: Noncor Infusion Sets; Noncor Port Infusion Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Med Supplies, Inc.
- Decided: Aug 29, 2002 after 148 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CMS Noncor Infusion Set(s) with or without Injection Site are designedrfior easy insertion inoto vascular access devices for safe administration of continuous and/or boulus infusion of pain control medications, chemotherapeutic agents and pharmaceuticals. CMS Noncor infusion set(s) are available in all commonly used needle gauges and lengths, sets include rnascrobore or microbore tubing with or without injection site.

Source page: https://510kreport.com/device/K021080
Methodology: https://510kreport.com/methodology