Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EBP · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121318 | PROSOFT | Perma Laboratories | 2012-06-06 | 35 | 0 |
| K101771 | RELINE-IT MODEL RELINE-IT | Majestic Drug Co., Inc. | 2010-09-20 | 88 | 0 |
| K790589 | DENTURE-TIGHT | Den-Mat Corp. | 1979-08-10 | 136 | 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