Corning Costar Corp.: FDA clearances and approvals
Corning Costar Corp. has 8 FDA 510(k) clearances (first 1980, latest 1987), across 4 product codes in 3 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | 5 | 5 |
| KJA | Flask, Tissue Culture | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 | 1 |
Review panels
- Microbiology (6)
- General Hospital (1)
- Pathology (1)
Most recent Corning Costar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871559 | CELL LIFTER | LIB | 1987-05-15 | 23 |
| K860703 | U - STAR (MICRO-STAR) | LHI | 1986-05-06 | 69 |
| K823137 | OCTAPETTES | JTC | 1982-12-03 | 39 |
| K823138 | CELL SCRAPER | KJA | 1982-11-29 | 35 |
| K803244 | ASSAY STRIPS | JTC | 1981-02-02 | 41 |
| K803243 | SEROCLUSTER FLEXIBLE VINYL U & V PL. | JTC | 1981-01-28 | 36 |
| K803242 | SEROCLUSTER EIA PLATES | JTC | 1981-01-28 | 36 |
| K800240 | SEROCLUSTER U AND V | JTC | 1980-02-13 | 8 |
Recalls
openFDA lists no recalls under a recalling firm named Corning Costar Corp..
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 Corning Costar Corp. have?
Corning Costar Corp. has 8 FDA 510(k) clearances (first 1980, latest 1987), across 4 product codes in 3 review panels.
How long does FDA take to clear Corning Costar Corp.'s 510(k)s?
The median time from FDA receipt to decision across Corning Costar Corp.'s cleared 510(k)s is 36 days.
What devices does Corning Costar Corp. make?
Its most frequent FDA product codes are JTC (Device, Microtiter Diluting/Dispensing, 5); KJA (Flask, Tissue Culture, 1); LHI (Set, I.V. Fluid Transfer, 1).
Has Corning Costar Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Corning Costar Corp. Related entities may recall under other names.
Next steps
- See all 8 Corning Costar Corp. clearances with predicates and recalls
- Run predicate analysis for product code JTC, Corning Costar Corp.'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.