Dow Corning Corp. Healthcare Industries Materials: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Dow Corning Corp. Healthcare Industries Materials” (first 1976, latest 1985), across 25 product codes in 9 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | 2 | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| EWL | Prosthesis, Laryngeal (Taub) | 1 | 1 |
| EXB | Collector, Ostomy | 1 | 1 |
| FIQ | Cannula, A-V Shunt | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Plus 15 more product codes.
Review panels
- Orthopedic (11)
- Gastroenterology and Urology (6)
- General and Plastic Surgery (5)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- General Hospital (1)
- Ophthalmic (1)
Most recent Dow Corning Corp. Healthcare Industries Materials 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853186 | SILASTIC INFLATABLE BONE PLUG H.P. | LZN | 1985-09-24 | 56 |
| K844637 | WHITESIDE ACRYLIC CEMENT SPACER SLEEVE | LTC | 1985-06-19 | 203 |
| K850255 | DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET | — | 1985-05-01 | 99 |
| K843995 | TF-II HIP PROSTHESIS | KWL | 1985-04-23 | 194 |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | KWL | 1984-12-20 | 171 |
| K840357 | SSA HIP PROSTHESIS | JDI | 1984-02-17 | 22 |
| K831479 | METAL-BACKED ACETABULAR CUP | DXQ | 1983-06-15 | 37 |
| K812864 | SILASTIC VOICE PROSTHESIS | EWL | 1981-11-24 | 42 |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | KXE | 1981-08-18 | 28 |
| K811679 | SILASTIC TENDON PASSER H.P. | HWQ | 1981-07-10 | 25 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dow Corning Corp. Healthcare Industries Materials.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dow Corning Corp. Healthcare Industries Materials?
FDA lists 31 510(k) clearances under the applicant name “Dow Corning Corp. Healthcare Industries Materials” (first 1976, latest 1985), across 25 product codes in 9 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 Dow Corning Corp. Healthcare Industries Materials?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dow Corning Corp. Healthcare Industries Materials is 41 days.
Which FDA product codes appear under Dow Corning Corp. Healthcare Industries Materials?
The most frequent FDA product codes under this applicant name are GBO (Catheter, Nephrostomy, General & Plastic Surgery, 2); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 2); KNT (Tubes, Gastrointestinal (And Accessories), 2).
Next steps
- See all 31 Dow Corning Corp. Healthcare Industries Materials clearances with predicates and recalls
- Run predicate analysis for product code GBO, Dow Corning Corp. Healthcare Industries Materials'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.