Gil-Med Industries C/O Kegan & Kegan, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Gil-Med Industries C/O Kegan & Kegan, Ltd.” (first 1984, latest 1988), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| KPE | Container, I.V. | 4 | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Gil-Med Industries C/O Kegan & Kegan, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880506 | MODIFIED EVA-MIX AND DI-MIX BAGS | KPE | 1988-05-20 | 102 |
| K870274 | DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER | KPE | 1987-02-10 | 14 |
| K861862 | DIETO CONTAINER FOR ENTERAL NUTRITION | KNT | 1986-08-11 | 90 |
| K841597 | GIL-MED PARENTERAL NUTRITION OR MEDICINE | KPE | 1984-10-26 | 191 |
| K841224 | URO-MALE INCONTINENCE CATHETER | KNX | 1984-05-02 | 41 |
| K840915 | DIMIX CONTAINER FOR PARNETERAL NUTRIT | KPE | 1984-04-17 | 48 |
| K840916 | DIETO CONTAINER FOR ENTERNAL NUTRIT | KNT | 1984-04-04 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Gil-Med Industries C/O Kegan & Kegan, Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gil-Med Industries C/O Kegan & Kegan, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Gil-Med Industries C/O Kegan & Kegan, Ltd.” (first 1984, latest 1988), across 3 product codes in 2 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 Gil-Med Industries C/O Kegan & Kegan, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gil-Med Industries C/O Kegan & Kegan, Ltd. is 48 days.
Which FDA product codes appear under Gil-Med Industries C/O Kegan & Kegan, Ltd.?
The most frequent FDA product codes under this applicant name are KPE (Container, I.V., 4); KNT (Tubes, Gastrointestinal (And Accessories), 2); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 1).
Next steps
- See all 7 Gil-Med Industries C/O Kegan & Kegan, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KPE, Gil-Med Industries C/O Kegan & Kegan, Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.