Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LHW · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820849 | BLUE RIDGE RABBIT BLOOD | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820848 | BLUE RIDGE SHEEP BLOOD | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K813513 | AFRICAN GREEN MONKEY BLOOD IN ALSERVERS | Dutchland Laboratories, Inc. | 1981-12-31 | 16 | 0 |
| K813512 | RHESUS MONKEY BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | 1981-12-29 | 14 | 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