PMA · Approved
Recalled · 2011Targis (T3) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urologix, LLC · MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Approved on Aug 22, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 179-day review. It has been recalled 4 times.
- Decided
- Aug 22, 1997
- Review
- 179 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.
P970008 has 62 supplements since 1997: 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 |
|---|---|
| 1997 | 3 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 4 |
| 2003 | 2 |
| 2005 | 4 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 9 |
| 2009 | 5 |
| 2010 | 6 |
| 2011 | 5 |
| 2012 | 3 |
| 2013 | 1 |
| 2015 | 2 |
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 |
|---|---|---|---|---|
| Apr 28, 2011 | Not classified | Z-2710-2011 | Nonconforming Material/Component | Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a RTU Plus balloon. The… |
| Feb 18, 2010 | Not classified | Z-1174-2010 | Incorrect or no expiration date | Urolgix is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis System. The reason for this Recall is a labeling error only; the issue involves a discrepancy in the"Use Before"… |
| Mar 16, 2007 | Not classified | Z-0720-2007 | Other | The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing. |
| Mar 16, 2007 | Not classified | Z-0721-2007 | Other | The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing. |
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/P970008 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970008: Targis (T3) System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970008
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026