Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Galenica Enterprises, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
787 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923656 | LIGHTING SOURCE SYSTEM | Galenica Enterprises, Inc. | 1994-09-08 | 787 | 0 |
| K896383 | DISPOSABLE EXTERNAL CLAMPS | Galenica Enterprises, Inc. | 1989-12-06 | 30 | 0 |
| K883283 | DISPOSABLE AMNIOTOME | Galenica Enterprises, Inc. | 1988-10-18 | 75 | 0 |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | Galenica Enterprises, Inc. | 1986-06-13 | 87 | 0 |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | Galenica Enterprises, Inc. | 1984-07-31 | 83 | 1 |
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