# K040032: Central Station, Version 3.3H

- Pathway: 510(k) (Traditional)
- Applicant: Hommed, LLC
- Decided: Feb 27, 2004 after 50 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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) HomMed Central Station: named in the summary without a submission number

## Indications for use
The HomMed Central Station intended use is to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric (over 12 years of age) patients within healthcare and home environments. Central Station, Version 3.311 includes a HL7 interface to transfer data from HomMed Central Station to vendor systems and storage media. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature, and weight. Additionally monitoring device data from optional commercial stand-alone products including glucometry, spirometry, prothrombin time, ECG and digital camera images can also be received, displayed and stored. The Central Station displays patient data and system alerts for review and interpretation by physicians and/or physician supervised nurses. Central Station is a retrospective data monitor system and is not intended for emergency use or real-time monitoring.

Source page: https://510kreport.com/device/K040032
Methodology: https://510kreport.com/methodology