Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Grandcor Medical Systems · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
194 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905480 | SPIROSCOPE | Grandcor Medical Systems | 1991-05-06 | 151 | 0 |
| K895547 | GRANDCOR/CARDIOLINE ECT STRESS TESTING | Grandcor Medical Systems | 1990-03-13 | 181 | 0 |
| K883410 | CARDIOMEGA-T | Grandcor Medical Systems | 1988-10-17 | 67 | 0 |
| K871890 | CARDIO-MEGA SYSTEM | Grandcor Medical Systems | 1987-06-12 | 28 | 0 |
| K864260 | APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) | Grandcor Medical Systems | 1987-05-11 | 194 | 0 |
| K864978 | APPLISCOPE | Grandcor Medical Systems | 1987-02-19 | 59 | 0 |
| K864581 | APPLIDYN | Grandcor Medical Systems | 1987-01-21 | 62 | 0 |
| K862375 | CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM | Grandcor Medical Systems | 1986-07-01 | 7 | 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