# K140085: Universa Percultaneous  Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Nov 18, 2014 after 309 days
- Product code: FEW (Catheter, Malecot)
- Device class: 2
- Regulation: 21 CFR 876.5090
- 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 K810368 (1981). 2 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931195: Percutaneous Drainage Loop Catheter Set, Cook Urological, Inc. (1993) Summary page 4.
- K810368: Vance Percutaneous Malecot Nephrostomy, Vance Products, Inc. (1981) Summary page 4.

## Most influential descendants
- K181097: Cook Cystostomy Catheter Set (2019), 1 descendant of its own
- K240514: AMT Low-Profile Suprapubic Catheter & Drainage Set (2024), 0 descendants of its own
- K211911: Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (2022), 0 descendants of its own
- K191498: Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (2020), 0 descendants of its own
- K181735: Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (2019), 0 descendants of its own

## Indications for use
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system. The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.

Source page: https://510kreport.com/device/K140085
Methodology: https://510kreport.com/methodology