Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FHX · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
144 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081990 | LUBRICANO STERILE GEL | Farco Pharma GmbH | 2008-12-05 | 144 | 0 |
| K951713 | BUTTON LUBRICATOR | Fibertech Instruments, Inc. | 1995-04-25 | 11 | 0 |
| K935548 | CATHEJELL S STERILE LUBRICATING JELLY | Pharmazeutische Fabrik Montavit GmbH | 1994-03-30 | 133 | 0 |
| K912132 | OPERAND LUBRICATING JELLY | General Medical Co. | 1991-08-07 | 85 | 0 |
| K780386 | K-Y LUBRICATING JELLY | Johnson & Johnson Professionals, Inc. | 1978-04-13 | 34 | 0 |
| K771364 | LUBE JEL | Travenol Laboratories, S.A. | 1977-08-02 | 8 | 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