Atlas FDA

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

Gambro Healthcare · Predicate Candidate Screening

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

256 daysmedian FDA review time
386 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERGambro Healthcare2000-10-263030
K990039GAMBRO DQM 200Gambro Healthcare2000-01-273860
K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSGambro Healthcare1999-04-212820
K982414GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTEGambro Healthcare1999-03-262560
K980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/Gambro Healthcare1999-02-243871
K982760COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TGambro Healthcare1998-11-04900
K982818HOSPAL TIPSTOPGambro Healthcare1998-10-21710
K974899GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO HGambro Healthcare1998-09-232672
K981681PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)Gambro Healthcare1998-08-11901
K981085GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEMGambro Healthcare1998-05-18540
K970253COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOGambro Healthcare1997-09-262470
K962427COBE CENTRYSYSTEM 700 HG HEMODIALYZERGambro Healthcare1996-09-20880
K954623REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONGambro Healthcare1996-08-283280

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