PMA · Approved
Recalled · 2009Prolieve Thermodilatation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medifocus, Inc. · MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Approved on Feb 19, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 332-day review. It has been recalled 4 times.
- Decided
- Feb 19, 2004
- Review
- 332 days
- Class
- Class III
- Product code
- MEQ
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030006 has 28 supplements since 2004: 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 |
|---|---|
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 5 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| 2018 | 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 |
|---|---|---|---|---|
| Jul 20, 2009 | Not classified | Z-1692-2009 | Process design | Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the… |
| May 4, 2006 | Not classified | Z-1248-06 | Other | A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or maintain recommended pressure. |
| Mar 22, 2006 | Not classified | Z-0843-06 | Other | Surgical treatment kits containing medical device components were mislabeled with extended expiration dates. |
| Jul 19, 2004 | Not classified | Z-1339-04 | Other | Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient. |
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/P030006 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030006: Prolieve Thermodilatation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030006
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026