Sterling Drug, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sterling Drug, Inc.” (first 1978, latest 1990), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 47 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| JTQ | Bath, Incubators/Water, All | 1 | 1 |
Review panels
- Dental (4)
- General Hospital (2)
- General and Plastic Surgery (2)
- Microbiology (1)
Most recent Sterling Drug, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901369 | GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II | KGN | 1990-06-05 | 74 |
| K896110 | BIOBRANE(R) II | KGN | 1989-11-28 | 36 |
| K875275 | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | JTQ | 1988-01-27 | 34 |
| K840260 | PERIOGRAF DURAPATITE 40-60 MESH | LYC | 1984-04-05 | 86 |
| K820164 | EMPTY STERILE CARPUJECT | FMF | 1982-02-24 | 35 |
| K820023 | CONAGRAF TM DURAPATITE CONES | LYC | 1982-02-24 | 50 |
| K813257 | ALVEOGRAF DURAPATITE(18-40 MESH) | DZE | 1982-01-05 | 47 |
| K813070 | PERIOGRAF | LYC | 1981-11-20 | 18 |
| K780209 | DILUTION SPIKE | FMI | 1978-04-10 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Sterling Drug, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sterling Diagnostics, Inc. (41 510(k)s)
- Sterling Medivations, Inc. (27 510(k)s)
- Sterling Biochemical, Inc. (15 510(k)s)
- Sterling Diagnostic Imaging, Inc. (7 510(k)s)
- Sterling Medical Devices, Inc. (2 510(k)s)
- Sterling Medical, Inc. (1 510(k)s)
- Sterling Multi-Products, Inc. (1 510(k)s)
- Sterling U.S.A., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterling Drug, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Sterling Drug, Inc.” (first 1978, latest 1990), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sterling Drug, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterling Drug, Inc. is 47 days.
Which FDA product codes appear under Sterling Drug, Inc.?
The most frequent FDA product codes under this applicant name are LYC (Bone Grafting Material, Synthetic, 3); KGN (Wound Dressing With Animal-Derived Material(S), 2); DZE (Implant, Endosseous, Root-Form, 1).
Next steps
- See all 9 Sterling Drug, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Sterling Drug, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.