# K982170: Fluidsense Fluid Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Fluidsense Corp.
- Decided: Nov 30, 1998 after 164 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: 2 generations back to K915571 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870991: Imed (R) Model 960A Volumetric Infusion Pump, Imed Corp. (1987) Summary page 1.
- K912928: Lifecare 4100 Pca Infuser Plus II, Abbott Laboratories (1991) Summary page 1.
- K960661: Maxcess Needle Free Connector (8200), Solopak Medical Products, Inc. (1996) Summary page 1.

## Indications for use
The device is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. The device is intended to control and monitor the flow of fluids, which may include: 1. Drugs and Electrolytes (e.g., cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.) 2. Whole Blood and Blood Products. The device is intended for use in: 1. Hospitals (e.g., burn / trauma units, cardiac catheter lab, critical / intensive care, delivery / post-partum, emergency room, general floor, labor / OR / anesthesia, medical / surgical, oncology, pediatrics / neonatal, post-anesthesia / recovery, etc.) 2. Outpatient / Surgical Centers and is intended for use by: 1. Trained health care professionals (e.g., nurses, physicians, anesthesiologists, etc.).

Source page: https://510kreport.com/device/K982170
Methodology: https://510kreport.com/methodology