510(k) · Cleared
ClearedUrgent PC Stimulator; Urgent PC Lead Set
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 21, 2010 as substantially equivalent to K071822 (Uroplasty, Inc., 2007) after a 112-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Oct 21, 2010
- Review
- 112 days
- Class
- Class II
- Product code
- NAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052025 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK052025 Urgent PC Neuromodulation SystemUroplasty, Inc. · 2005
- 2 generations backK061333 Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12Uroplasty, Inc. · 2006
- 1 generation backK071822 Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Uroplasty, Inc. · 2007
- This deviceK101847 Urgent PC Stimulator; Urgent PC Lead SetUroplasty, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK132561 Nuro Neuromodulation SystemAdvanced Uro-Solutions, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132561Nuro Neuromodulation SystemAdvanced Uro-Solutions, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052025 | Urgent PC Neuromodulation System | Uroplasty, Inc. | 2005 | — |
| −2 | K061333 | Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 | Uroplasty, Inc. | 2006 | — |
| −1 | K071822 | Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 | Uroplasty, Inc. | 2007 | — |
| 0 (this device) | K101847 | Urgent PC Stimulator; Urgent PC Lead Set | Uroplasty, Inc. | 2010 | — |
| +1 | K132561 | Nuro Neuromodulation System | Advanced Uro-Solutions, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071822 | Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Summary page 1…er 8, 2010 New Device Name Urgento PC Neuromodulation System OCT 2 1 2010 Predicate Device Urgent® PC Neuromodulation System (K071822) Contact Uroplasty, Inc. 5420 Feltl Road Minnetonka, MN 553… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132561 | Nuro Neuromodulation System | 2013 | 0 |
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132561 (Advanced Uro-Solutions, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071822.
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. 2010, this device’s year, is highlighted.
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 with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101847: Urgent PC Stimulator; Urgent PC Lead Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101847
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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