# K041915: Hemo-Dop

- Pathway: 510(k) (Traditional)
- Applicant: Dwl Elektronische Systeme GmbH
- Decided: Aug 4, 2004 after 19 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930458 (1995). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951449: Model KM-25, Koven Technology, Inc. (1996) Summary page 1.
- K930458: Multi-Dop L, Dantec Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K052067: Doppler Guided Proctoscope, Model 500H (2005), 5 descendants of its own
- K070815: THD (2007), 4 descendants of its own
- K081429: THD Slide (2008), 3 descendants of its own
- K090009: THD Slide One (2009), 1 descendant of its own
- K150718: Wi-3 HAL-RAR System (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K041915
Methodology: https://510kreport.com/methodology