510(k) · Cleared
ClearedNuro Neuromodulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Uro-Solutions, Inc. · NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Cleared on Nov 5, 2013 as substantially equivalent to K101847 (Uroplasty, Inc., 2010) after an 82-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Nov 5, 2013
- Review
- 82 days
- Class
- Class II
- Product code
- NAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K052025 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK052025 Urgent PC Neuromodulation SystemUroplasty, Inc. · 2005
- 3 generations backK061333 Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12Uroplasty, Inc. · 2006
- 2 generations backK071822 Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Uroplasty, Inc. · 2007
- 1 generation backK101847 Urgent PC Stimulator; Urgent PC Lead SetUroplasty, Inc. · 2010
- This deviceK132561 Nuro Neuromodulation SystemAdvanced Uro-Solutions, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K052025 | Urgent PC Neuromodulation System | Uroplasty, Inc. | 2005 | — |
| −3 | 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 | — |
| −1 | K101847 | Urgent PC Stimulator; Urgent PC Lead Set | Uroplasty, Inc. | 2010 | — |
| 0 (this device) | K132561 | Nuro Neuromodulation System | Advanced Uro-Solutions, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K101847 | Urgent PC Stimulator; Urgent PC Lead SetSummary page 1…DEVICE Class 11,per 876.5310 CLASSIFICATION Product Code: NAM AND PRODUCT CODE: PREDICATE Urgent PC, K101847 DEVICE NAME: SUBSTANTIAL EQUIVALENCE: The NURO Neuromodulation System is substantially equivalent to the leg… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
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. 2013, 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 NURO Neuromadulation System (Stimulator model NURO 100) 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/K132561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132561: Nuro 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/K132561
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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