# K040985: Pump Connectivity Interface

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 30, 2004 after 229 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. The FDA summary names its predicate without a number.
- (no number) Alaris Medley System with MMS: named in the summary without a submission number
- (no number) B. Braun Horizon Outlook with DoseCorn: named in the summary without a submission number

## Indications for use
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices. The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. It enables remote viewing of pump status within the hospital and enables comparisons of pharmacy-entered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order. The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar display/computing device. The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.

Source page: https://510kreport.com/device/K040985
Methodology: https://510kreport.com/methodology