Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NAM · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
539 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System | Avation Medical, Inc. | 2023-04-03 | 410 | 0 |
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021-03-19 | 539 | 0 |
| K132561 | NURO NEUROMODULATION SYSTEM | Advanced Uro-Solutions, Inc. | 2013-11-05 | 82 | 0 |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Uroplasty, Inc. | 2010-10-21 | 112 | 0 |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-1 | Uroplasty, Inc. | 2007-08-20 | 48 | 0 |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250 | Uroplasty, Inc. | 2006-07-03 | 52 | 0 |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Uroplasty, Inc. | 2005-10-17 | 82 | 0 |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATO | Urosurge, Inc. | 2000-02-09 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda