# K020418: GO Medical Patient Controlled Analgesia Devices

- Pathway: 510(k) (Traditional)
- Applicant: P.T. Greenleaf
- Decided: Apr 29, 2003 after 446 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Go Medical Patient Controlled Analcesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following. legend: “Caution : Federal Law restricts this device to sale by or on the order of a physician”. (21 CFR 801.109(b)(l))

Source page: https://510kreport.com/device/K020418
Methodology: https://510kreport.com/methodology