# K983454: Pain Care 2000

- Pathway: 510(k) (Traditional)
- Applicant: Breg, Inc.
- Decided: Dec 16, 1998 after 77 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices 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.

## Most influential descendants
- K992551: Alpha Infusion Pump (1999), 5 descendants of its own
- K021964: Alpha Infusion Pump and Catheters (2002), 4 descendants of its own
- K042246: Multi-Drip Infusion Catheter (2004), 1 descendant of its own
- K071532: Alpha Infusion Pump,  Model A200, A450 (2008), 0 descendants of its own
- K061661: Sta Cath Attachable Infision Catheter, Model STA20 (2006), 0 descendants of its own

## Indications for use
BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).

Source page: https://510kreport.com/device/K983454
Methodology: https://510kreport.com/methodology