# DEN190020: iTind System

- Pathway: De Novo (Direct)
- Applicant: Medi-Tate, Ltd.
- Decided: Feb 25, 2020 after 329 days
- Product code: QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia)
- Device class: 2
- Regulation: 21 CFR 876.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K253525: Urocross Expander System (Model Numbers ES2018 and ES3025) (2026), 1 descendant of its own
- K261342: Urocross Expander System (UES-2018-C1) (2026), 0 descendants of its own
- K210138: iTind System (2021), 0 descendants of its own

## Indications for use
The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

Source page: https://510kreport.com/device/DEN190020
Methodology: https://510kreport.com/methodology