510(k) · Cleared
ClearedPrecision Plus Tuna Office System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidamed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 23, 2002 after a 28-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Jan 23, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK014224 Precision Plus Tuna Office SystemVidamed, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
- Descendant · 2 generations on · 9 of its ownK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK150786 Rezum SystemNxthera, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · cites it directly10descendants
- K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · 2 generations on9descendants
- K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Urologix, Inc. · 2015 · 3 generations on8descendants
- K150786Rezum SystemNxthera, Inc. · 2015 · 3 generations on7descendants
- K160417Rezum SystemNxthera, Inc. · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014224 | Precision Plus Tuna Office System | Vidamed, Inc. | 2002 | — |
| +1 | K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005 | 1 |
| +2 | K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator | Medtronic, Inc. | 2012 | 2 |
| +3 | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF… | Urologix, Inc. | 2015 | — |
| +3 | K150786 | Rezum System | Nxthera, Inc. | 2015 | — |
| +4 | K160417 | Rezum System | Nxthera, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Precision™ TUNA® Office System Named without a submission number | |
| * | — | PROVu™ TUNA® System Named without a submission number |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052413 (Medtronic Vascular, 2005) has gone furthest, with 10 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Precision™ Plus TUNA® Office System is indicated for use in the treatment
of symptoms due to urinary outflow obstruction secondary to Benign Prostatic
Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and
50 cc.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014224: Precision Plus Tuna Office System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014224
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026