# P950014: Prostatron

- Pathway: PMA
- Applicant: Urologix, Inc.
- Decided: May 3, 1996 after 382 days
- Product code: MEQ (System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Dec 10, 2003 · Not classified · Z-0345-04: During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay updates to the rectal 

Source page: https://510kreport.com/device/P950014
Methodology: https://510kreport.com/methodology