Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gil-Med Industries C/O Kegan & Kegan, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
191 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880506 | MODIFIED EVA-MIX AND DI-MIX BAGS | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1988-05-20 | 102 | 0 |
| K870274 | DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1987-02-10 | 14 | 0 |
| K861862 | DIETO CONTAINER FOR ENTERAL NUTRITION | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1986-08-11 | 90 | 0 |
| K841597 | GIL-MED PARENTERAL NUTRITION OR MEDICINE | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-10-26 | 191 | 0 |
| K841224 | URO-MALE INCONTINENCE CATHETER | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-05-02 | 41 | 0 |
| K840915 | DIMIX CONTAINER FOR PARNETERAL NUTRIT | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-04-17 | 48 | 0 |
| K840916 | DIETO CONTAINER FOR ENTERNAL NUTRIT | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-04-04 | 35 | 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