Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tissue Culture Innovations · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
9 daysmedian FDA review time
9 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860787 | DULBECCO'S MEM | Tissue Culture Innovations | 1986-03-12 | 9 | 0 |
| K860784 | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | Tissue Culture Innovations | 1986-03-12 | 9 | 0 |
| K860786 | RPMI 1640 HEPES | Tissue Culture Innovations | 1986-03-12 | 9 | 0 |
| K860785 | HAM'S F-12 W/NAHCO3 | Tissue Culture Innovations | 1986-03-12 | 9 | 0 |
| K860783 | MICRO CARRIER | Tissue Culture Innovations | 1986-03-12 | 9 | 0 |
| K860788 | HAM'S F-12 W/GLUTAMINE & NAHCO3 | Tissue Culture Innovations | 1986-03-12 | 9 | 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