510(k) · Cleared
ClearedTHD Revolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thd Spa · JAF Monitor, Ultrasonic, Nonfetal
Cleared on Feb 24, 2015 as substantially equivalent to K070815 (G.F. S.R.L., 2007) and 2 other predicates after a 249-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Feb 24, 2015
- Review
- 249 days
- Class
- Class II
- Product code
- JAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K930458 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930458 Multi-Dop LDantec Medical, Inc. · 1995
- 5 generations backK041915 Hemo-DopDwl Elektronische Systeme GmbH · 2004
- 4 generations backK052067 Doppler Guided Proctoscope, Model 500HMultigon Industries, Inc. · 2005
- 3 generations backK070815 THDG.F. S.R.L. · 2007
- 2 generations backK081429 THD SlideThd Spa · 2008
- 1 generation backK090009 THD Slide OneThd Spa · 2009
- This deviceK141657 THD RevolutionThd Spa · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930458 | Multi-Dop L | Dantec Medical, Inc. | 1995 | — |
| −5 | K041915 | Hemo-Dop | Dwl Elektronische Systeme GmbH | 2004 | — |
| −4 | K052067 | Doppler Guided Proctoscope, Model 500H | Multigon Industries, Inc. | 2005 | — |
| −3 | K070815 | THD | G.F. S.R.L. | 2007 | — |
| −2 | K081429 | THD Slide | Thd Spa | 2008 | — |
| −1 | K090009 | THD Slide One | Thd Spa | 2009 | — |
| 0 (this device) | K141657 | THD Revolution | Thd Spa | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JAF? 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 JAF device
- #1 K242487 Laminar P1 (LDH-HW-001)score 10.3 · 7 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K070815 | THDSummary page 4…llowing devices: Applicant Device name 510(k) Number G.F. S.R.L. THD K070815 THD SpA THD Slide K081429 THD SpA THD Slide… | 2007 |
| * | K081429 | THD SlideSummary page 4…510(k) Number G.F. S.R.L. THD K070815 THD SpA THD Slide K081429 THD SpA THD Slide One K090009 CONFIDENTIAL… | 2008 |
| * | K090009 | THD Slide OneSummary page 4…K070815 THD SpA THD Slide K081429 THD SpA THD Slide One K090009 CONFIDENTIAL Page… | 2009 |
| † | K091490 | Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes | 2009 |
| † | K041515 | Truglyde Absorbable Polyglycolic Acid Surgical Suture | 2005 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K070815.
How does its category compare?
All JAF devicesJAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JAF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAF
Too few JAF 510(k)s in any year since 2007 to give a median.
Recalls per year · JAF
No recall names JAF since 2007.
Adverse event reports per year · JAF
1in 2023
MAUDE reports naming product code JAF, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 44 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique. The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits. THD Revolution and its accessories may exclusively be used by specialist physicians…
Read the full statement (109 words)
The THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique.
The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits.
THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorroidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality "Light Source", to support the different THD diagnostic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141657: THD Revolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141657
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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