Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Concepts, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110659 | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM | Medical Concepts, Inc. | 2011-09-13 | 190 | 0 |
| K940283 | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM | Medical Concepts, Inc. | 1994-09-28 | 252 | 0 |
| K883944 | MEC-1 VIDEO COMBO SYSTEM | Medical Concepts, Inc. | 1988-09-28 | 9 | 0 |
| K883943 | CCM-1 VIDEO CAMERA SYSTEM | Medical Concepts, Inc. | 1988-09-28 | 9 | 0 |
| K802564 | MEDICAL MAGNETIC TAPE RECORDER | Medical Concepts, Inc. | 1980-11-12 | 26 | 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