# K052025: Urgent PC Neuromodulation System

- Pathway: 510(k) (Traditional)
- Applicant: Uroplasty, Inc.
- Decided: Oct 17, 2005 after 82 days
- Product code: NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K992069: UroSurge Percutaneous SANS Device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K061333: Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 (2006), 5 descendants of its own
- K071822: Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 (2007), 4 descendants of its own
- K192731: ZIDA Wearable Neuromodulation System (2021), 1 descendant of its own
- K101847: Urgent PC Stimulator; Urgent PC Lead Set (2010), 1 descendant of its own
- K220454: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (2023), 0 descendants of its own

## Indications for use
The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

Source page: https://510kreport.com/device/K052025
Methodology: https://510kreport.com/methodology