Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Stiefel Research Institute, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
186 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914591 | L.C.S. 2000 SYSTEM | Stiefel Research Institute, Inc. | 1992-01-14 | 90 | 0 |
| K910216 | STEADFAST DENTURE ADHESIVE POWDER | Stiefel Research Institute, Inc. | 1991-03-29 | 71 | 0 |
| K895818 | STEADFAST DENTURE ADHESIVE CREAM | Stiefel Research Institute, Inc. | 1990-04-03 | 186 | 0 |
| K895817 | HERMAL WOUND CARE KIT | Stiefel Research Institute, Inc. | 1990-01-19 | 112 | 0 |
| K896724 | CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. | Stiefel Research Institute, Inc. | 1990-01-09 | 41 | 0 |
| K893996 | CUSIS ULTRASOUND SKIN IMAGING SYSTEM | Stiefel Research Institute, Inc. | 1989-09-21 | 108 | 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