# K990101: Pain Control Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sgarlato Laboratories, Inc.
- Decided: Mar 19, 1999 after 66 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 K896422 (1990). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 1.

## Most influential descendants
- K992551: Alpha Infusion Pump (1999), 5 descendants of its own
- K021964: Alpha Infusion Pump and Catheters (2002), 4 descendants of its own
- K042246: Multi-Drip Infusion Catheter (2004), 1 descendant of its own
- K071532: Alpha Infusion Pump,  Model A200, A450 (2008), 0 descendants of its own
- K061661: Sta Cath Attachable Infision Catheter, Model STA20 (2006), 0 descendants of its own

## Indications for use
The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter. The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment. The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.

Source page: https://510kreport.com/device/K990101
Methodology: https://510kreport.com/methodology