Atlas FDA

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

Sartorius Filters, Inc. — Predicate Candidate Screening

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

115 daysmedian FDA review time
120 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K851818SARTORIUS MINI SART FH 16592Sartorius Filters, Inc.1985-08-191150
K851817SARTORIUS MINI-SART FH 16555Sartorius Filters, Inc.1985-08-191150
K851816SARTORIUS MINISART FH 16534Sartorius Filters, Inc.1985-08-191150
K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYSSartorius Filters, Inc.1985-06-041200
K844504SARTORIUS MINISART SM 16596HYSartorius Filters, Inc.1985-01-18590
K830487HEMO-PROCESSING SYSTEMSartorius Filters, Inc.1983-04-28720
K823132SARTOPHOR SYSTEM FOR ELECTROPHORESISSartorius Filters, Inc.1982-11-27330
K822285CELLULOSE ACETATE MEMBRANE STRIPSSartorius Filters, Inc.1982-09-21532

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