# K955019: Urotract I

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Dec 6, 1995 after 34 days
- Product code: KQS (Table, Cystometric, Non-Electric And Accessories)
- Device class: 1
- Regulation: 21 CFR 876.4890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122768: Genesis (2013), 4 descendants of its own
- K133434: Genesis II (2014), 2 descendants of its own
- K151485: Genesis (2015), 1 descendant of its own
- K220871: Nautilus (2022), 0 descendants of its own
- K130729: Extra Corporeal Shockwave Lithotripter (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K955019
Methodology: https://510kreport.com/methodology