# K810368: Vance Percutaneous Malecot Nephrostomy

- Pathway: 510(k) (Traditional)
- Applicant: Vance Products, Inc.
- Decided: Mar 20, 1981 after 36 days
- Product code: KOB (Catheter, Suprapubic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: 3 (0 Class I)
- 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

## Recalls of this device
- Apr 22, 2019 · Class II · Z-1370-2019: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
- Jan 4, 2019 · Class II · Z-0968-2020: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- Jan 4, 2019 · Class II · Z-0969-2020: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Source page: https://510kreport.com/device/K810368
Methodology: https://510kreport.com/methodology