Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life Technologies, Inc. — 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) |
|---|---|---|---|---|---|
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | 2012-06-21 | 202 | 1 |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | Life Technologies, Inc. | 2001-02-16 | 59 | 0 |
| K953719 | HUMAN TUBAL FLUID | Life Technologies, Inc. | 1995-11-06 | 89 | 0 |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G | Life Technologies, Inc. | 1995-08-11 | 113 | 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