Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Conception Technologies — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

43 daysmedian FDA review time
317 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030850ENHANCE HUMAN SERUM ALBUMINConception Technologies2003-04-08220
K023655ENHANCE HTF MEDIUM WITH HEPESConception Technologies2002-12-13440
K023717SPERM WASH MEDIUM WITH GENTAMICINConception Technologies2002-12-13380
K020490PBS, PBSW WITH CATIONS AND PHENOL REDConception Technologies2002-03-28430
K01148110% PVP; 10% PVP IN EBSS SOLUTIONConception Technologies2001-07-02490
K011573HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUMConception Technologies2001-07-02420
K011462OIL FOR TISSUE CULTUREConception Technologies2001-06-13300
K993140WATER FOR TISSUE CULTURE, MODELS 1500Conception Technologies2000-08-023170

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