# K992015: Freedom Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Novacon Corp.
- Decided: Sep 10, 1999 after 87 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) PainBuster system: named in the summary without a submission number

## Indications for use
1) Freedom™ is intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management. 2) Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump. 3) Freedom™is a single use only device. 4) Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment. 5) Freedom™is not intended for epidural, subcutaneous,” or vascular drug delivery. 6) Freedom™is not intended for use with chemotherapy drugs. 7) Freedom™is not intended for use with blood, blood products, or TPN.

Source page: https://510kreport.com/device/K992015
Methodology: https://510kreport.com/methodology