Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Columbus Instruments Intl. Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
320 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895791 | OXYMAX | Columbus Instruments Intl. Corp. | 1990-03-28 | 181 | 0 |
| K861543 | CARDIOMAX-II | Columbus Instruments Intl. Corp. | 1987-03-10 | 320 | 0 |
| K861100 | ISO-THERMEX | Columbus Instruments Intl. Corp. | 1986-05-12 | 49 | 0 |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | 1979-01-23 | 49 | 0 |
| K771718 | CARDIOTHERM-500X | Columbus Instruments Intl. Corp. | 1977-09-28 | 16 | 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