510(k) · Cleared
ClearedThermoflex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argomed, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Aug 26, 1999 as substantially equivalent to K965199 (Vidamed, Inc., 1997) and 4 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 26, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K951245 (1995). 8 ancestors in all, the oldest K913477 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 2 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 1 generation backK965199 Tuna 5 CatheterVidamed, Inc. · 1997
- This deviceK991847 Thermoflex SystemArgomed, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −2 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −1 | K965199 | Tuna 5 Catheter | Vidamed, Inc. | 1997 | — |
| 0 (this device) | K991847 | Thermoflex System | Argomed, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K965199 | Tuna 5 CatheterSummary page 3…eristics, clinical efficacy, and clinical safety as a combination of several class II predicate devices, the VidaMed, Inc. Transurethral Needle Ablation (“TUNA”) system (K965199, K960918, and K951245), the Trimedyne Optilase® Nd:YAG Laser (“VLAP”) system (K954597), and the Apex Prostatic Balloon Dilatation… | 1997 |
| * | K960918 | Vidamed Tuna (Transurethral Needle Ablation) SystemSummary page 3…clinical efficacy, and clinical safety as a combination of several class II predicate devices, the VidaMed, Inc. Transurethral Needle Ablation (“TUNA”) system (K965199, K960918, and K951245), the Trimedyne Optilase® Nd:YAG Laser (“VLAP”) system (K954597), and the Apex Prostatic Balloon Dilatation Catheter… | 1996 |
| * | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge)…Summary page 1…evard Suite 308 Morrisville, North Carolina 27560 (919) 469-2340 (919) 469-2779 Richard B. Klein May 28, 1999 Manufacturer 510(k) K965129, K960218, VidaMed, Inc. and K951245 Trimedyne, Inc. K954597 Apex K913477 The Thermoflex system, the VidaMed TUNA system, and the Trimedyne VLAP system have the same… | 1995 |
| * | K954597 | Right Angle Laser FibersSummary page 1…ille, North Carolina 27560 (919) 469-2340 (919) 469-2779 Richard B. Klein May 28, 1999 Manufacturer 510(k) K965129, K960218, VidaMed, Inc. and K951245 Trimedyne, Inc. K954597 Apex K913477 The Thermoflex system, the VidaMed TUNA system, and the Trimedyne VLAP system have the same intended use: to provid… | 1996 |
| * | K913477 | Apex (TM) Prostatic Balloon Dilation CatheterSummary page 1…arolina 27560 (919) 469-2340 (919) 469-2779 Richard B. Klein May 28, 1999 Manufacturer 510(k) K965129, K960218, VidaMed, Inc. and K951245 Trimedyne, Inc. K954597 Apex K913477 The Thermoflex system, the VidaMed TUNA system, and the Trimedyne VLAP system have the same intended use: to provide thermal tre… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K965199.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Thermoflex system is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (‘BPH”). It is indicated for use in men over the age of 50 years with prostate lengths between 2.0 cm and 6.4 cm who present symptoms of urinary outflow obstruction secondary to BPH.
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/K991847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991847: Thermoflex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991847
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026