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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Otisville Biopharm, Inc. · Predicate Candidate Screening

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

52 daysmedian FDA review time
115 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874176BIOTIS (TM) HAEMOPHILUS DUCREYIOtisville Biopharm, Inc.1988-02-051150
K874179BIOTIS (TM) SABHI (DOUBLE POUR)Otisville Biopharm, Inc.1988-01-281070
K874174BIOTIS (TM) STARCH HYDROLYSIS WITH BCPOtisville Biopharm, Inc.1987-12-04520
K874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXACOtisville Biopharm, Inc.1987-12-04520
K874177BIOTIS (TM) BCYEOtisville Biopharm, Inc.1987-12-04500
K874178BIOTIS (TM) BCYE SELECTIVEOtisville Biopharm, Inc.1987-12-04520
K874172BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)Otisville Biopharm, Inc.1987-10-28150
K874173BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXIOtisville Biopharm, Inc.1987-10-28150

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