Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bradstreet Clinical Research Assoc., Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972859 | FLUTTER D | Bradstreet Clinical Research Assoc., Inc. | 1998-06-05 | 305 | 0 |
| K951182 | RYDER CONTACT LENS CASE MODEL 10670 | Bradstreet Clinical Research Assoc., Inc. | 1995-05-16 | 61 | 0 |
| K951181 | RYDER CONTACT LENS CASE | Bradstreet Clinical Research Assoc., Inc. | 1995-05-12 | 57 | 0 |
| K946083 | FLUTTER(R) | Bradstreet Clinical Research Assoc., Inc. | 1995-03-13 | 90 | 1 |
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