Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B C Medical , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
218 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946378 | BCM 400CP | B C Medical , Ltd. | 1995-05-04 | 132 | 0 |
| K933100 | ARC-600 | B C Medical , Ltd. | 1993-11-08 | 137 | 0 |
| K933035 | BCM-600TX | B C Medical , Ltd. | 1993-10-08 | 108 | 0 |
| K920862 | BCM-400C | B C Medical , Ltd. | 1992-09-30 | 218 | 0 |
| K890306 | BCM-ARC 105 X-RAY MOBILE UNIT | B C Medical , Ltd. | 1989-04-17 | 84 | 0 |
| K870205 | ROTAX-II BI-PLANE CIRCULAR ARM | B C Medical , Ltd. | 1987-03-06 | 45 | 0 |
| K801949 | BCM-302 COLLIMATING CONE & COMPENSATIN | B C Medical , Ltd. | 1980-10-03 | 49 | 0 |
| K801950 | BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO | B C Medical , Ltd. | 1980-10-03 | 49 | 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