Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pureway Compliance, Inc. · 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) |
|---|---|---|---|---|---|
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, | Pureway Compliance, Inc. | 2025-10-14 | 118 | 0 |
| K231484 | PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. | 2023-09-14 | 114 | 0 |
| K151249 | PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTO | Pureway Compliance, Inc. | 2015-09-04 | 115 | 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