# K110429: Prosim 4, Prosim 6, Prosim 8

- Pathway: 510(k) (Traditional)
- Applicant: Fluke Biomedical
- Decided: Sep 2, 2011 after 199 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
Longest line of descent: 1 generation back to K935817 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935817: Medsim 300 Patient Simulator, Dynatech/Nevada, Inc. (1994) Summary page 1.
- K933519: Index SPO2 Simulator, Bio-Tek Instruments, Inc. (1994) Summary page 7.
- (no number) Cufflink: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K974293: Index 2. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 7.

## Indications for use
The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations: * ECG - adult or neonatal * Invasive and non-invasive blood pressure * Respiration The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations: * ECG - adult or pediatric * Invasive and non-invasive blood pressure * Respiration * Temperature * Cardiac Output * Fetal Simulation - includes fetal, maternal ECG, & uterine contractions (ProSim 8 only) Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional

Source page: https://510kreport.com/device/K110429
Methodology: https://510kreport.com/methodology