Isle Media and Sterile Products, Inc.: FDA clearances and approvals
Isle Media and Sterile Products, Inc. has 93 FDA 510(k) clearances (first 1979, latest 1983), across 12 product codes in 1 review panel. Median 510(k) review time: 29 days.
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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | 17 | 17 |
| JSJ | Culture Media, Selective And Non-Differential | 17 | 17 |
| JSG | Culture Media, Non-Selective And Non-Differential | 15 | 15 |
| JSI | Culture Media, Selective And Differential | 15 | 15 |
| JSC | Culture Media, General Nutrient Broth | 6 | 6 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 5 | 5 |
| JSD | Culture Media, Selective Broth | 4 | 4 |
| JSM | Culture Media, Non-Propagating Transport | 4 | 4 |
| JSE | Culture Media, Multiple Biochemical Test | 3 | 3 |
| JSF | Culture Media, Single Biochemical Test | 3 | 3 |
Plus 2 more product codes.
Review panels
- Microbiology (93)
Most recent Isle Media and Sterile Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831671 | MODIFIED SOYBEAN CASEIN DIGEST BROTH | JSG | 1983-07-28 | 66 |
| K821218 | CAMPY-S AGAR | JSJ | 1982-05-14 | 17 |
| K820863 | MEDIA FOR IN-VITRO DIAGNOSTIC USE | JSJ | 1982-04-16 | 18 |
| K812798 | MOTILITY GI MEDIUM | JSG | 1981-10-20 | 14 |
| K812797 | SCHAEDLER AGARS | JSG | 1981-10-20 | 14 |
| K812796 | ANAEROBIC CNA BLOOD AGAR | JSJ | 1981-10-20 | 14 |
| K812795 | ANAEROBIC BLOOD AGAR | JSG | 1981-10-20 | 14 |
| K800818 | CHLAMYDOSPORE AGAR | JSH | 1980-04-24 | 13 |
| K800807 | CORN MEAL AGAR MEDIA | JSJ | 1980-04-24 | 14 |
| K800334 | MARTIN-LEWIS AGAR | JTY | 1980-03-03 | 18 |
83 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Isle Media and Sterile Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Isle Media and Sterile Products, Inc. have?
Isle Media and Sterile Products, Inc. has 93 FDA 510(k) clearances (first 1979, latest 1983), across 12 product codes in 1 review panel.
How long does FDA take to clear Isle Media and Sterile Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Isle Media and Sterile Products, Inc.'s cleared 510(k)s is 29 days.
What devices does Isle Media and Sterile Products, Inc. make?
Its most frequent FDA product codes are JSH (Culture Media, Non-Selective And Differential, 17); JSJ (Culture Media, Selective And Non-Differential, 17); JSG (Culture Media, Non-Selective And Non-Differential, 15).
Has Isle Media and Sterile Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Isle Media and Sterile Products, Inc. Related entities may recall under other names.
Next steps
- See all 93 Isle Media and Sterile Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSH, Isle Media and Sterile Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.