Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MCF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
181 daysmedian FDA review time
209 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023662 | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER | Hwadong International Company , Ltd. | 2003-05-28 | 209 | 0 |
| K021258 | GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER | Germ Terminator Corporation | 2002-05-10 | 21 | 0 |
| K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Otres, LLC | 2001-06-06 | 204 | 0 |
| K901459 | DS60 TOOTHBRUSH SANITIZER | Associated Mills, Inc. | 1990-09-17 | 173 | 0 |
| K896481 | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER | Purebrush Assoc. | 1990-05-15 | 181 | 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