Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dey Laboratories, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
120 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972778 | DEY VIAL SODIUM CHLORIDE 3% | Dey Laboratories, Inc. | 1997-10-08 | 75 | 0 |
| K910239 | NEBU-SOL METERED DOSE DISPENSER (TM) | Dey Laboratories, Inc. | 1991-05-22 | 120 | 0 |
| K880411 | DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE | Dey Laboratories, Inc. | 1988-02-29 | 28 | 0 |
| K875011 | DEY-PAK PURIFIED WATER, USP, STERILE | Dey Laboratories, Inc. | 1988-01-22 | 49 | 0 |
| K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | Dey Laboratories, Inc. | 1988-01-22 | 49 | 0 |
| K831532 | OCULAR IRRIGATING CANNULA | Dey Laboratories, Inc. | 1983-07-12 | 60 | 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