# K021274: Pain-Mate Pain Management System with Dual Port 1+1, 2+2, Models 2C1718, 2C1719

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 17, 2002 after 25 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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. The FDA summary names its predicate without a number.
- (no number) Infusor SV Elastomeric Infusion Device: named in the summary without a submission number
- (no number) Infusor LV Elastomeric Infusion Device: named in the summary without a submission number

## Indications for use
The Dual Port Infusor line of elastomeric pumps is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Source page: https://510kreport.com/device/K021274
Methodology: https://510kreport.com/methodology