# K990425: Sidekick Infusion Kit

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Apr 23, 1999 after 71 days
- Product code: FRN (Pump, Infusion)
- 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
Longest line of descent: 4 generations back to K896422 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984146: Paragon Infusion, I-Flow Corp. (1999) Summary page 2.
- K923875: Sidekick 50 Plus and Sidekick 100 Plus, I-Flow Corp. (1993) Summary page 2.
- K980558: Painbuster Infusion System, I-Flow Corp. (1998) Summary page 2.
- K982946: Painbuster Infusion Kit, I-Flow Corp. (1998) Summary page 2.
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 2.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 2.
- K982256: Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump, Mckinley, Inc. (1998) Summary page 2.

## Indications for use
The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.

Source page: https://510kreport.com/device/K990425
Methodology: https://510kreport.com/methodology