Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Med Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
107 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823286 | MODELS DPT 1000/DPT 1000NS | Bio-Med Corp. | 1982-12-30 | 56 | 0 |
| K810735 | DISPOSABLE, STERILE TRANSDUCER DOMES | Bio-Med Corp. | 1981-05-08 | 51 | 0 |
| K802092 | HF-100 DIALYZER | Bio-Med Corp. | 1980-12-18 | 107 | 0 |
| K801985 | BIO-MED CORP. DISP. NON-STERILE TRANSDU | Bio-Med Corp. | 1980-09-09 | 21 | 0 |
| K802069 | DISP. TRANSDUCER DOMES TD200 & TD300 | Bio-Med Corp. | 1980-09-09 | 13 | 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