# K161323: Solution Set for Epidural Use

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Nov 30, 2016 after 203 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
Longest line of descent: 1 generation back to K925058 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925058: Bard Ambu Pump Spik Tub Set Pacret Provid Pump Set, C.R. Bard, Inc. (1993) Summary page 4.

## Indications for use
For the administration of fluids from a container into the patient’s epidural space with Baxter infusion pumps.

Source page: https://510kreport.com/device/K161323
Methodology: https://510kreport.com/methodology