Atlas FDA

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

JSA · Predicate Candidate Screening

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

10 daysmedian FDA review time
41 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881534ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGARAcumedia Manufacturers, Inc.1988-04-18100
K881536ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGARAcumedia Manufacturers, Inc.1988-04-18100
K881537ANTIBIOTIC MEDIUM #19Acumedia Manufacturers, Inc.1988-04-18100
K881538ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGARAcumedia Manufacturers, Inc.1988-04-18100
K881535ANTIBIOTIC MEDIUM #6Acumedia Manufacturers, Inc.1988-04-18100
K832577SEED AGARAcumedia Manufacturers, Inc.1983-09-12410
K832576BASE AGARAcumedia Manufacturers, Inc.1983-09-12410
K832575ANTIBIOTIC ASSAY BROTHAcumedia Manufacturers, Inc.1983-09-12410

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