Atlas FDA

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

Ocean Scientific, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time
96 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K893810IMMUNO-WASH AUTOMATED TUBE WASHEROcean Scientific, Inc.1989-08-03730
K873638MICRO-CHEM ANALYZEROcean Scientific, Inc.1987-09-29200
K864731OCEAN SCIENTIFIC VDRL TESTOcean Scientific, Inc.1987-03-10960
K863976OCEAN SCIENTIFIC VACUTESTOcean Scientific, Inc.1986-10-24100
K860987MINI-CHEM ANALYZEROcean Scientific, Inc.1986-05-05490
K840340CHEM-STAT ANALYZEROcean Scientific, Inc.1984-03-23580

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