# K131249: ON-Q Painbuster, on-Q C-Bloc, Homepump Eclipse, Homepump C-Series

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow, LLC
- Decided: Feb 3, 2014 after 278 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 no predicate by number.

## Indications for use
'the I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, subcutaneous, and epidural. The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into interoperative sites (infiltration), percutaneous and epidural. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared to narcotic-only pain management. The indications for use include hospital, alternate care, ambulatory and home environments.

Source page: https://510kreport.com/device/K131249
Methodology: https://510kreport.com/methodology