# K991363: 30 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump, Pain Management, Pcea Pump, Epidu

- Pathway: 510(k) (Special)
- Applicant: Sorenson Medical, Inc.
- Decided: May 13, 1999 after 23 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Indications for All Pumps are for the infusion of fluids and medications into a body. The 30 Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.

Source page: https://510kreport.com/device/K991363
Methodology: https://510kreport.com/methodology