Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oak Ridge Products, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | 2016-06-09 | 43 | 0 |
| K141759 | OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS | Oak Ridge Products, LLC | 2014-10-24 | 115 | 0 |
| K130281 | OAK RIDGE PRODUCTS SHARP CONTAINER | Oak Ridge Products, LLC | 2013-06-21 | 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