Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Halifax Biomedical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
218 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182880 | Halifax Imaging Kit | Halifax Biomedical, Inc. | 2018-10-31 | 16 | 0 |
| K133966 | MODEL-BASED RSA SOFTWARE | Halifax Biomedical, Inc. | 2014-03-06 | 72 | 0 |
| K121345 | SR SUITE 1.0 | Halifax Biomedical, Inc. | 2012-06-01 | 28 | 0 |
| K103417 | HALIFAX BIOMEDICAL TANATLUM BEAD SET | Halifax Biomedical, Inc. | 2011-06-28 | 218 | 0 |
| K090581 | TANTALUM BEAD SET, MODEL P003175 | Halifax Biomedical, Inc. | 2009-08-21 | 171 | 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