Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Corp. of America · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860956 | KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST. | Medical Corp. of America | 1986-06-02 | 81 | 0 |
| K860957 | DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT. | Medical Corp. of America | 1986-06-02 | 81 | 0 |
| K854116 | PHACO PACKS, 1A PACKS & PACK COMPONENTS | Medical Corp. of America | 1985-12-27 | 80 | 0 |
| K853883 | TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR | Medical Corp. of America | 1985-10-08 | 19 | 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