Atlas FDA

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

Cobe Renal Care, Inc. — Predicate Candidate Screening

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

504 daysmedian FDA review time
664 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOCobe Renal Care, Inc.1997-09-256640
K955592COBE CENTRYSYSTEM 14 PES HEMODIALYZERSCobe Renal Care, Inc.1997-04-305100
K955487GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERSCobe Renal Care, Inc.1997-04-185040
K946279PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)Cobe Renal Care, Inc.1997-02-107760
K954003COBE HEMODYNAMIC RECIRCULATION MONITORCobe Renal Care, Inc.1997-02-065310
K960474COBE CENTRYSYSTEM 600 HG HEMODIALYZERSCobe Renal Care, Inc.1996-08-141940
K944436COBE CENTRYSYSTEM CS 200 DIALYZERCobe Renal Care, Inc.1996-01-295040
K951311GAMBRO HC 14R HEMOCONCENTRATORCobe Renal Care, Inc.1996-01-112950
K952342GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERSCobe Renal Care, Inc.1995-09-151190
K945746GAMBRO LUNDIA 94-500 DIALYZERCobe Renal Care, Inc.1995-09-082890
K945747GAMBRO LUNDIA 94-600 DIALYZERCobe Renal Care, Inc.1995-09-082890
K933883GAMBRO FH 66 D HEMOFILTERCobe Renal Care, Inc.1995-03-135800
K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.1994-09-074050
K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.1994-08-263930

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