Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corning Costar Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
69 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871559 | CELL LIFTER | Corning Costar Corp. | 1987-05-15 | 23 | 0 |
| K860703 | U - STAR (MICRO-STAR) | Corning Costar Corp. | 1986-05-06 | 69 | 0 |
| K823137 | OCTAPETTES | Corning Costar Corp. | 1982-12-03 | 39 | 0 |
| K823138 | CELL SCRAPER | Corning Costar Corp. | 1982-11-29 | 35 | 0 |
| K803244 | ASSAY STRIPS | Corning Costar Corp. | 1981-02-02 | 41 | 0 |
| K803243 | SEROCLUSTER FLEXIBLE VINYL U & V PL. | Corning Costar Corp. | 1981-01-28 | 36 | 0 |
| K803242 | SEROCLUSTER EIA PLATES | Corning Costar Corp. | 1981-01-28 | 36 | 0 |
| K800240 | SEROCLUSTER U AND V | Corning Costar Corp. | 1980-02-13 | 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