Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cost Rite Health Products, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
100 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891141 | CARERITE FACE MASK | Cost Rite Health Products, Inc. | 1989-04-18 | 46 | 0 |
| K890667 | RUBBER DAM | Cost Rite Health Products, Inc. | 1989-03-29 | 48 | 0 |
| K873705 | CARERITE FACE MASK | Cost Rite Health Products, Inc. | 1987-10-05 | 21 | 0 |
| K871798 | FILM AND PAPER COMBINATION STERILIZING BAG | Cost Rite Health Products, Inc. | 1987-07-21 | 75 | 0 |
| K871736 | CARERITE BIOPACK GINGIVAL RETRACTION CORD | Cost Rite Health Products, Inc. | 1987-05-27 | 22 | 0 |
| K870147 | CARERITE & COST RITE NYLON STERILIZATION FILM | Cost Rite Health Products, Inc. | 1987-04-23 | 100 | 0 |
| K870906 | CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 | Cost Rite Health Products, Inc. | 1987-03-30 | 25 | 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