Atlas FDA

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

JRL — Predicate Candidate Screening

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

27 daysmedian FDA review time
119 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K822121ACRO PACKGelman Sciences, Inc.1982-08-05170
K820455CENTRIFREE MICROPARTITION SYSTEMAmicon, Inc.1982-03-15240
K820224EMIT FREELEVEL SYSTEM ISyva Co.1982-02-23270
K812750IL 703, STAT SEPARATORInstrumentation Laboratory CO1982-01-261190
K813159VACUSHIELD TMGelman Sciences, Inc.1981-12-08220
K810829ACRODISCGelman Sciences, Inc.1981-04-08140
K801500ULTRAFREE CALCIUM FILTERMillipore Corp.1980-08-20540
K790445ULTRA-FREEMillipore Corp.1979-06-281150
K781043CEA-IMMERSIBLE SEPARATORMillipore Corp.1978-09-15870

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