# K031566: Syndeo Pca Syringe Pump, Model 2L3113

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 19, 2003 after 92 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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. The FDA summary names its predicate without a number.
- (no number) PCA II Syringe Infusion Pump: named in the summary without a submission number
- (no number) iPump Pain Management System: named in the summary without a submission number

## Recalls of this device
- Jul 6, 2005 · Not classified · Z-1373-05: During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attemp

## Indications for use
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications. The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings. The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.

Source page: https://510kreport.com/device/K031566
Methodology: https://510kreport.com/methodology