# K052999: Semperflo Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 22, 2006 after 148 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) On-Q Pain Pump: named in the summary without a submission number
- (no number) VICRYL* Suture: named in the summary without a submission number
- (no number) BAXTER Pain Management System: named in the summary without a submission number

## Indications for use
The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate. The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings. The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions. When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows: The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management. The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.

Source page: https://510kreport.com/device/K052999
Methodology: https://510kreport.com/methodology