# K954428: Solopicc 24 (60CM) 20GA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Douglas Medical Products Corp.
- Decided: Mar 28, 1996 after 188 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801575 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801575: L-Cath Intravenous Placement Unit, Luther Medical Products, Inc. (1980) Summary page 1.
- K914378: Peripheral Intervenous Catheter, Medical Profiles, Inc. (1993) Summary page 1.

## Indications for use
The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

Source page: https://510kreport.com/device/K954428
Methodology: https://510kreport.com/methodology