# K211649: PCEA Syringe Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Nov 23, 2021 after 179 days
- Product code: PWH (Administrations Sets With Neuraxial Connectors)
- 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: 4 generations back to K965017 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors, Smiths Medical Asd, Inc. (2017) Summary page 5.

## Indications for use
For the administration of anesthetics and/or analgesics from a syringe into the patient’s epidural space through an epidural access device.

Source page: https://510kreport.com/device/K211649
Methodology: https://510kreport.com/methodology