# K020544: Wing Safe Infusion Set 20 GA, SHS2000 Series; Wing Safe Infusion Set 19 GA, SHS1900 Series; Wing Safe Infusion Set 22 GA

- Pathway: 510(k) (Special)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Mar 12, 2002 after 25 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 16, 2010 · Not classified · Z-1333-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

## Indications for use
The Churchill Medical Systems Wing Safe Huber Type Needle Sets intended use is for the delivery of medical fluids into implantable chemotherapy ports.

Source page: https://510kreport.com/device/K020544
Methodology: https://510kreport.com/methodology