Atlas FDA

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

MSF · Predicate Candidate Screening

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

383 daysmedian FDA review time
514 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023615GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LRGambro Renal Products2003-05-061900
K994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERGambro Healthcare2000-10-263030
K970679ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1998-07-235140
K970681ALTRA NOVA 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1998-07-235140
K970653CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOWBaxter Healthcare Corp1998-03-113830
K970662CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)Baxter Healthcare Corp1998-03-113830
K970663CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-1Baxter Healthcare Corp1998-01-113240
K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2Renal Systems, Inc.1998-01-053190

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