Bfi- Medical Waste Systems: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bfi- Medical Waste Systems” (first 1982, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (3)
- Radiology (2)
Most recent Bfi- Medical Waste Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981184 | SHARPTRACK REUSABLE SHARPS CONTAINER | FMI | 1998-06-22 | 82 |
| K943771 | MEDX REUSABLE SHARPS CONTAINER | FMI | 1995-03-03 | 213 |
| K943794 | MX4000 | FMI | 1994-12-14 | 133 |
| K923356 | MEDX ROTATIONAL GANTRY SYSTEM | IYX | 1992-09-21 | 75 |
| K843582 | MULTI-FORMAT FILM CAMERA | LMC | 1984-10-25 | 44 |
| K827761 | MED-X MODEL 301 X-RAY FILTER | — | 1982-08-10 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Bfi- Medical Waste Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bfi- Medical Waste Systems?
FDA lists 6 510(k) clearances under the applicant name “Bfi- Medical Waste Systems” (first 1982, latest 1998), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bfi- Medical Waste Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bfi- Medical Waste Systems is 78 days.
Which FDA product codes appear under Bfi- Medical Waste Systems?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 3); IYX (Camera, Scintillation (Gamma), 1); LMC (Camera, Multi Format, Radiological, 1).
Next steps
- See all 6 Bfi- Medical Waste Systems clearances with predicates and recalls
- Run predicate analysis for product code FMI, Bfi- Medical Waste Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.