# K013928: Pain Care 3200

- Pathway: 510(k) (Special)
- Applicant: Breg, Inc.
- Decided: Dec 3, 2001 after 5 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.
18 later devices descend from it; 1 cites it directly.
1 of 19 devices in its family (counting itself) has 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.
- (no number) Pain Care 3000: named in the summary without a submission number

## Most influential descendants
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit (2002), 17 descendants of its own
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits (2003), 15 descendants of its own
- K032642: Beeline System (2003), 8 descendants of its own
- K042228: Beeline Motiv, Propolis, Pca (2004), 7 descendants of its own
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit (2005), 6 descendants of its own

## Indications for use
BREG's Pain Care 3200 has the same intended use as BREG’s Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. The purpose of BREG's Pain Care 3000 and 3200 is to provide 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/K013928
Methodology: https://510kreport.com/methodology