B C Medical , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “B C Medical , Ltd.” (first 1980, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | 2 | 2 |
| KPX | Changer, Radiographic Film/Cassette | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| JZW | Nephelometer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (6)
- Immunology (1)
Most recent B C Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946378 | BCM 400CP | IZI | 1995-05-04 | 132 |
| K933100 | ARC-600 | JAA | 1993-11-08 | 137 |
| K933035 | BCM-600TX | KPX | 1993-10-08 | 108 |
| K920862 | BCM-400C | IZI | 1992-09-30 | 218 |
| K890306 | BCM-ARC 105 X-RAY MOBILE UNIT | IZL | 1989-04-17 | 84 |
| K870205 | ROTAX-II BI-PLANE CIRCULAR ARM | — | 1987-03-06 | 45 |
| K801950 | BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO | KPX | 1980-10-03 | 49 |
| K801949 | BCM-302 COLLIMATING CONE & COMPENSATIN | JZW | 1980-10-03 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named B C Medical , Ltd..
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 B C Medical , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “B C Medical , Ltd.” (first 1980, latest 1995), across 6 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 B C Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name B C Medical , Ltd. is 96 days.
Which FDA product codes appear under B C Medical , Ltd.?
The most frequent FDA product codes under this applicant name are IZI (System, X-Ray, Angiographic, 2); KPX (Changer, Radiographic Film/Cassette, 2); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 8 B C Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IZI, B C Medical , Ltd.'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.