510(k) · Cleared
ClearedTHD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.F. S.R.L. · JAF Monitor, Ultrasonic, Nonfetal
Cleared on Jun 20, 2007 as substantially equivalent to K041915 (Dwl Elektronische Systeme GmbH, 2004) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 20, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- JAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930458 (1995). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930458 Multi-Dop LDantec Medical, Inc. · 1995
- 2 generations backK041915 Hemo-DopDwl Elektronische Systeme GmbH · 2004
- 1 generation backK052067 Doppler Guided Proctoscope, Model 500HMultigon Industries, Inc. · 2005
- This deviceK070815 THDG.F. S.R.L. · 2007
- Descendant · cites it directly · 3 of its ownK081429 THD SlideThd Spa · 2008
- Descendant · 2 generations on · 1 of its ownK090009 THD Slide OneThd Spa · 2009
- Descendant · 2 generations on · 0 of its ownK150718 Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015
- Descendant · cites it directly · 0 of its ownK141657 THD RevolutionThd Spa · 2015
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930458 | Multi-Dop L | Dantec Medical, Inc. | 1995 | — |
| −2 | K041915 | Hemo-Dop | Dwl Elektronische Systeme GmbH | 2004 | — |
| −1 | K052067 | Doppler Guided Proctoscope, Model 500H | Multigon Industries, Inc. | 2005 | — |
| 0 (this device) | K070815 | THD | G.F. S.R.L. | 2007 | — |
| +1 | K081429 | THD Slide | Thd Spa | 2008 | — |
| +2 | K090009 | THD Slide One | Thd Spa | 2009 | — |
| +2 | K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015 | — |
| +1 | K141657 | THD Revolution | Thd Spa | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 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? (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 |
|---|---|---|---|
| * | K041915 | Hemo-DopSummary page 1…ollowing devices: Applicant Device name 510(k) Number DWL-Electronische HEMO-DOP K041915 Systeme GmbH Multigon Industries, Inc. DOPPLER GUIDED K052067… | 2004 |
| * | K052067 | Doppler Guided Proctoscope, Model 500HSummary page 1…ber DWL-Electronische HEMO-DOP K041915 Systeme GmbH Multigon Industries, Inc. DOPPLER GUIDED K052067 PROCTOSCOPE Model 500H CONFIDE… | 2005 |
What descends from it? (4)
2 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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081429 (Thd Spa, 2008) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K041915.
How does its category compare?
All JAF devicesJAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and a needle holder included in the THD Kit.
The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070815 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070815: THD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070815
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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