Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNG · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
176 daysmedian FDA review time
391 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Personal Products Co. | 2001-04-30 | 82 | 0 |
| K983164 | RESTORE (AKA RE/STOR) | Nebl, Inc. | 1999-03-05 | 176 | 0 |
| K974600 | UROMED PATCH | Uromed Corp. | 1998-03-31 | 112 | 0 |
| K974645 | FEMASSIST FLEXIBLE | Insight Medical Corp. | 1998-02-12 | 62 | 0 |
| K971359 | RESTORE (A.K.A. CAPSURE) | Nebl, Inc. | 1997-11-14 | 217 | 0 |
| K963858 | FEMASSIST URINARY DEVICE | Insight Medical Corp. | 1997-10-21 | 391 | 0 |
| K954215 | MINIGUARD | Advanced Surgical Intervention, Inc. | 1996-05-08 | 243 | 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