510(k) · Cleared
ClearedUrgent PC Neuromodulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uroplasty, Inc. · NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Cleared on Oct 17, 2005 after an 82-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 82 days
- Class
- Class II
- Product code
- NAM
- Recalls
- None
- Predicates
- 1
6 later devices descend from it, 1 citing it directly.
- This deviceK052025 Urgent PC Neuromodulation SystemUroplasty, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK061333 Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12Uroplasty, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK071822 Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Uroplasty, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK192731 ZIDA Wearable Neuromodulation SystemExodus Innovations · 2021
- Descendant · 3 generations on · 1 of its ownK101847 Urgent PC Stimulator; Urgent PC Lead SetUroplasty, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK220454 Vivally System Wearable, Non-Invasive Neuromodulation System and…Avation Medical, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061333Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12Uroplasty, Inc. · 2006 · cites it directly5descendants
- K071822Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Uroplasty, Inc. · 2007 · 2 generations on4descendants
- K192731ZIDA Wearable Neuromodulation SystemExodus Innovations · 2021 · 3 generations on1descendant
- K101847Urgent PC Stimulator; Urgent PC Lead SetUroplasty, Inc. · 2010 · 3 generations on1descendant
- K220454Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile ApplicationAvation Medical, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052025 | Urgent PC Neuromodulation System | Uroplasty, Inc. | 2005 | — |
| +1 | K061333 | Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 | Uroplasty, Inc. | 2006 | — |
| +2 | K071822 | Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 | Uroplasty, Inc. | 2007 | — |
| +3 | K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021 | — |
| +3 | K101847 | Urgent PC Stimulator; Urgent PC Lead Set | Uroplasty, Inc. | 2010 | — |
| +4 | K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile… | Avation Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NAM device
- #1 K220454 Vivally System Wearable, Non-Invasive…score 6.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…(k) Summary Date Prepared July 26, 2005 New Device Name Urgent® PC Neuromodulation System Predicate Device UioSurge® Percutaneous SANSm Device (K992069) Contact Uroplasty, Inc. 2718 Summer Street NE Minneapolis, MN 5… |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061333 | Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 | 2006 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061333 (Uroplasty, Inc., 2006) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NAM devicesNAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAM
Too few NAM 510(k)s in any year since 2007 to give a median.
Recalls per year · NAM
No recall names NAM since 2007.
Adverse event reports per year · NAM
3in 2023
MAUDE reports naming product code NAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 52 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Urgent PC Neuromodulation System is intended to
treat patients suffering from urinary urgency, urinary
frequency, and urge incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052025: Urgent PC Neuromodulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026