Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202542 | Allura Vaginal Stent | Pmt Corporation | 2020-09-30 | 28 | 0 |
| K983045 | AMIELLE | Owen Mumford USA, Inc. | 1998-11-25 | 85 | 0 |
| K974479 | SILIMED VAGINAL STENT | Silimed, LLC | 1998-08-05 | 252 | 0 |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | Bioteque America, Inc. | 1995-11-08 | 1365 | 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