Stiefel Research Institute, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Stiefel Research Institute, Inc.” (first 1989, latest 1992), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 99 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KOM | Adhesive, Denture, Acacia And Karaya With Sodium Borate | 1 | 1 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- Dental (2)
- Radiology (1)
Most recent Stiefel Research Institute, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914591 | L.C.S. 2000 SYSTEM | GEH | 1992-01-14 | 90 |
| K910216 | STEADFAST DENTURE ADHESIVE POWDER | KOM | 1991-03-29 | 71 |
| K895818 | STEADFAST DENTURE ADHESIVE CREAM | KOT | 1990-04-03 | 186 |
| K895817 | HERMAL WOUND CARE KIT | NAD | 1990-01-19 | 112 |
| K896724 | CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. | GEH | 1990-01-09 | 41 |
| K893996 | CUSIS ULTRASOUND SKIN IMAGING SYSTEM | IYO | 1989-09-21 | 108 |
Recalls
openFDA lists no recalls under a recalling firm named Stiefel Research Institute, 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.
- Stiefel Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stiefel Research Institute, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Stiefel Research Institute, Inc.” (first 1989, latest 1992), across 5 product codes in 3 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 Stiefel Research Institute, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stiefel Research Institute, Inc. is 99 days.
Which FDA product codes appear under Stiefel Research Institute, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1); KOM (Adhesive, Denture, Acacia And Karaya With Sodium Borate, 1).
Next steps
- See all 6 Stiefel Research Institute, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Stiefel Research Institute, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.