# K931195: Percutaneous Drainage Loop Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Dec 22, 1993 after 288 days
- Product code: KOD (Catheter, Urological)
- 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K140085: Universa Percultaneous  Drainage Catheter (2014), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K931195
Methodology: https://510kreport.com/methodology