# K212262: PCA Syringe Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 3, 2022 after 440 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: 2 generations back to K003225 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112893: Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets, Baxter Healthcare Corporation (2011) Summary page 5.

## Indications for use
For the administration of fluids from a container into the patient's vascular system through a vascular access device. For use in adult populations only.

Source page: https://510kreport.com/device/K212262
Methodology: https://510kreport.com/methodology