# K020881: Modification to Personal Infusor Local Pain Management Procedural Kit

- Pathway: 510(k) (Special)
- Applicant: Science Incorporated
- Decided: Mar 27, 2002 after 9 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: 1 generation back to K010824 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010824: Personal Infusor Local Pain Management Procedural Kit, Science Incorporated (2001) Summary page 1.

## Indications for use
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications direcdy into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor’s administration line, which is attached to a catheter. The Personal Infusor is portable and is suitable for use by ambulatory patients. The Personal Infusor is intended for single use only. The Personal Infusor is not intended for rapid infusion, intravenous or intra-arterial drug infusion, for the delivery of blood, blood products, lipids, or fat emulsions, or for use by patients with a history of allergic reactions to anesthetics.

Source page: https://510kreport.com/device/K020881
Methodology: https://510kreport.com/methodology