# K173533: Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Poiesis Medical, LLC
- Decided: Mar 29, 2018 after 134 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K941488 (1994). 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)
- K941488: Devmed Double-Balloon Urological Catheter, Medical Technology Development Corp. (1994) Summary page 4.

## Indications for use
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

Source page: https://510kreport.com/device/K173533
Methodology: https://510kreport.com/methodology