Dey Laboratories, Inc.: FDA clearances and approvals
Dey Laboratories, Inc. has 6 FDA 510(k) clearances (first 1983, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time: 54 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
Review panels
- Anesthesiology (5)
- Ophthalmic (1)
Most recent Dey Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972778 | DEY VIAL SODIUM CHLORIDE 3% | CAF | 1997-10-08 | 75 |
| K910239 | NEBU-SOL METERED DOSE DISPENSER (TM) | BSY | 1991-05-22 | 120 |
| K880411 | DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE | CAF | 1988-02-29 | 28 |
| K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | CCQ | 1988-01-22 | 49 |
| K875011 | DEY-PAK PURIFIED WATER, USP, STERILE | CCQ | 1988-01-22 | 49 |
| K831532 | OCULAR IRRIGATING CANNULA | HMX | 1983-07-12 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Dey Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Dey Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Dey Laboratories, Inc. have?
Dey Laboratories, Inc. has 6 FDA 510(k) clearances (first 1983, latest 1997), across 4 product codes in 2 review panels.
How long does FDA take to clear Dey Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dey Laboratories, Inc.'s cleared 510(k)s is 54 days.
What devices does Dey Laboratories, Inc. make?
Its most frequent FDA product codes are CAF (Nebulizer (Direct Patient Interface), 2); CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer), 2); BSY (Catheters, Suction, Tracheobronchial, 1).
Has Dey Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dey Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 6 Dey Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Dey Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.