Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bfi- Medical Waste Systems — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
213 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981184 | SHARPTRACK REUSABLE SHARPS CONTAINER | Bfi- Medical Waste Systems | 1998-06-22 | 82 | 0 |
| K943771 | MEDX REUSABLE SHARPS CONTAINER | Bfi- Medical Waste Systems | 1995-03-03 | 213 | 0 |
| K943794 | MX4000 | Bfi- Medical Waste Systems | 1994-12-14 | 133 | 0 |
| K923356 | MEDX ROTATIONAL GANTRY SYSTEM | Bfi- Medical Waste Systems | 1992-09-21 | 75 | 0 |
| K843582 | MULTI-FORMAT FILM CAMERA | Bfi- Medical Waste Systems | 1984-10-25 | 44 | 0 |
| K827761 | MED-X MODEL 301 X-RAY FILTER | Bfi- Medical Waste Systems | 1982-08-10 | 29 | 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