PMA · Approved
Recalled · 2003Prostatron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urologix, Inc. · MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Approved on May 3, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 382-day review. It has been recalled once.
- Decided
- May 3, 1996
- Review
- 382 days
- Class
- Class III
- Product code
- MEQ
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P950014 has 26 supplements since 1996: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1996 | 5 |
| 1997 | 5 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| 2005 | 3 |
| 2008 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2003 | Not classified | Z-0345-04 | Other | 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 temperature reading. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MEQ devicesMEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEQ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MEQ
Too few MEQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MEQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEQ
1in 2018
MAUDE reports naming product code MEQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | — | 2 | 35 |
| 2008 | 14 | — | 0 | 358 |
| 2009 | 10 | — | 1 | 350 |
| 2010 | 7 | — | 1 | 75 |
| 2011 | 6 | — | 1 | 52 |
| 2012 | 4 | — | 0 | 16 |
| 2013 | 2 | — | 0 | 7 |
| 2014 | 4 | — | 0 | 22 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P950014 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950014: Prostatron.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950014
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026