510(k) · Cleared
ClearedHemo-Dop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dwl Elektronische Systeme GmbH · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 4, 2004 as substantially equivalent to K951449 (Koven Technology, Inc., 1996) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Aug 4, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930458 (1995). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930458 Multi-Dop LDantec Medical, Inc. · 1995
- This deviceK041915 Hemo-DopDwl Elektronische Systeme GmbH · 2004
- Descendant · cites it directly · 5 of its ownK052067 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K052067Doppler Guided Proctoscope, Model 500HMultigon Industries, Inc. · 2005 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930458 | Multi-Dop L | Dantec Medical, Inc. | 1995 | — |
| 0 (this device) | K041915 | Hemo-Dop | Dwl Elektronische Systeme GmbH | 2004 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K951449 | Model KM-25Summary page 1…Dop®) Class: Regulatory Class 11 K951449 Predicate Device: KOVEN TECHNOLOGY INC.; Model KM-25… | 1996 |
| * | K930458 | Multi-Dop LSummary page 1…te Device: KOVEN TECHNOLOGY INC.; Model KM-25 K930458 DWL Elektronische Systeme, GmbH; Multi-Dop®D L E3 Performance Standards Performance Standa… | 1995 |
What descends from it? (6)
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?
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Hemo-Dop® is a medical device to detect blood vessels supplying haemorrhoids and the subsequent HAL for haemorrhoids of state II and III. It can also be used as useful Supplement when doing sclero-therapy and Barron ligature. Using the 8 MHz pencil probe it can be used for measuring the blood flow velocities in arteries and veins subcutaneously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041915: Hemo-Dop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041915
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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