# K103336: MPS450 Multiparameter Simulator

- Pathway: 510(k) (Traditional)
- Applicant: Fluke Biomedical
- Decided: Apr 13, 2011 after 149 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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) MedSim300B: named in the summary without a submission number

## Indications for use
The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications. The MPS450 provides the following function categories: ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional)

Source page: https://510kreport.com/device/K103336
Methodology: https://510kreport.com/methodology