# K851144: Ureteral Dilation Set

- Pathway: 510(k) (Traditional)
- Applicant: Van-Tec, Inc.
- Decided: Apr 9, 1985 after 19 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K172527: Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe (2017), 1 descendant of its own
- K213334: Monarch Platform, Urology (2022), 0 descendants of its own
- K180756: Safety Wire Guide Introducer (2018), 0 descendants of its own
- K180028: Cook 810 Set, Desilets-Hoffman Introducer Set (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K851144
Methodology: https://510kreport.com/methodology