# K951449: Model KM-25

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: May 20, 1996 after 418 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041915: Hemo-Dop (2004), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K951449
Methodology: https://510kreport.com/methodology