510(k) · Cleared
ClearedDoppler Guided Proctoscope, Model 500H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Multigon Industries, Inc. · JAF Monitor, Ultrasonic, Nonfetal
Cleared on Aug 29, 2005 as substantially equivalent to K951449 (Koven Technology, Inc., 1996) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 29, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- JAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930458 (1995). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930458 Multi-Dop LDantec Medical, Inc. · 1995
- 1 generation backK041915 Hemo-DopDwl Elektronische Systeme GmbH · 2004
- This deviceK052067 Doppler Guided Proctoscope, Model 500HMultigon Industries, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK070815 THDG.F. S.R.L. · 2007
- Descendant · 2 generations on · 3 of its ownK081429 THD SlideThd Spa · 2008
- Descendant · 3 generations on · 1 of its ownK090009 THD Slide OneThd Spa · 2009
- Descendant · 3 generations on · 0 of its ownK150718 Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK141657 THD RevolutionThd Spa · 2015
Most influential descendants
Showing 5 of 5 · See all- K070815THDG.F. S.R.L. · 2007 · cites it directly4descendants
- K081429THD SlideThd Spa · 2008 · 2 generations on3descendants
- K090009THD Slide OneThd Spa · 2009 · 3 generations on1descendant
- K150718Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015 · 3 generations on0descendants
- K141657THD RevolutionThd Spa · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930458 | Multi-Dop L | Dantec Medical, Inc. | 1995 | — |
| −1 | K041915 | Hemo-Dop | Dwl Elektronische Systeme GmbH | 2004 | — |
| 0 (this device) | K052067 | Doppler Guided Proctoscope, Model 500H | Multigon Industries, Inc. | 2005 | — |
| +1 | K070815 | THD | G.F. S.R.L. | 2007 | — |
| +2 | K081429 | THD Slide | Thd Spa | 2008 | — |
| +3 | K090009 | THD Slide One | Thd Spa | 2009 | — |
| +3 | K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K951449 | Model KM-25Summary page 2…s: Trade or Proprietary Name Manufacturer 510(k) Number Model KM-25 Koven Technology Inc. k951449 Hemo-Dop DWL Elektronische Systeme,GmbH k041915 The 500H includes Cuda Products Corp/ Sun… | 1996 |
| * | K041915 | Hemo-DopSummary page 2…er Model KM-25 Koven Technology Inc. k951449 Hemo-Dop DWL Elektronische Systeme,GmbH k041915 The 500H includes Cuda Products Corp/ Sun Optics Light Source Model 1-150 510k # k893491 and Cuda Products Corp/Sunoptics fiber… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070815 | THD | 2007 | 4 |
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 10 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070815 (G.F. S.R.L., 2007) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K951449.
How does its category compare?
All JAF devicesJAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Model 500H Doppler Guided Proctoscope is used to detect blood vessels supplying hemorrhoids and for performing HAL (Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052067: Doppler Guided Proctoscope, Model 500H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052067
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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