# K210138: iTind System

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Tate, Ltd.
- Decided: Jun 25, 2021 after 157 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
Longest line of descent: 1 generation back to DEN190020 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190020: iTind System, Medi-Tate, Ltd. (2020) Summary page 4.

## 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/K210138
Methodology: https://510kreport.com/methodology