Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LDH · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950822 | SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL | Solopak Laboratories, Inc. | 1995-03-22 | 28 | 0 |
| K883686 | STERILE EMPTY GLASS VIALS | Farris Laboratories, Inc. | 1988-09-23 | 25 | 0 |
| K875227 | STERILE EMPTY VIALS | Allertech, Inc. | 1988-03-04 | 73 | 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