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

National Medical Care, Medical Products Div., Inc. · Predicate Candidate Screening

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

79 daysmedian FDA review time
228 days90th percentile
62clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETNational Medical Care, Medical Products Div., Inc.1996-11-011572
K941757FORMALIN REUSE CARTNational Medical Care, Medical Products Div., Inc.1996-01-226540
K952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYNational Medical Care, Medical Products Div., Inc.1995-12-222170
K930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000National Medical Care, Medical Products Div., Inc.1994-08-315590
K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-RNational Medical Care, Medical Products Div., Inc.1993-03-054990
K920029DEXTROLYTE II CAPD TRNSFER SETNational Medical Care, Medical Products Div., Inc.1992-09-212620
K920586DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SETNational Medical Care, Medical Products Div., Inc.1992-09-212240
K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.1992-09-212200
K920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMPNational Medical Care, Medical Products Div., Inc.1992-09-212200
K920797HEMODIALYSIS BLOOD TUBING SETNational Medical Care, Medical Products Div., Inc.1992-09-212130
K914363PERITONEAL DIALYSIS CYCLER SETNational Medical Care, Medical Products Div., Inc.1992-03-161670
K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMPNational Medical Care, Medical Products Div., Inc.1992-03-16900
K905809NMC CYCLER MACHINENational Medical Care, Medical Products Div., Inc.1992-02-254250
K902451LONG-LIFE Y-SET CAT. NO. 48-6366-8National Medical Care, Medical Products Div., Inc.1990-08-14740
K903021NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630National Medical Care, Medical Products Div., Inc.1990-08-14340
K901688ARTERIAL/VENOUS BLOODLINESNational Medical Care, Medical Products Div., Inc.1990-08-021120
K900018HOLLOW FIBER DIALYZER, BIO CARE PS 130National Medical Care, Medical Products Div., Inc.1990-07-272060
K895792DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6National Medical Care, Medical Products Div., Inc.1990-03-231760
K895992CATHETER EXTENSION SET CAT. NO. 48-3027-9National Medical Care, Medical Products Div., Inc.1990-03-231610
K895990DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SETNational Medical Care, Medical Products Div., Inc.1990-03-221600
K895991PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6National Medical Care, Medical Products Div., Inc.1990-03-221600
K896599DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)National Medical Care, Medical Products Div., Inc.1990-03-221210
K896600DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1National Medical Care, Medical Products Div., Inc.1990-03-221210
K900008DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SETNational Medical Care, Medical Products Div., Inc.1990-03-22790
K900012DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SETNational Medical Care, Medical Products Div., Inc.1990-03-22790
K900140DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3National Medical Care, Medical Products Div., Inc.1990-03-22700
K900141DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6National Medical Care, Medical Products Div., Inc.1990-03-22700
K900142DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2National Medical Care, Medical Products Div., Inc.1990-03-22700
K900226DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6National Medical Care, Medical Products Div., Inc.1990-03-22640
K900242DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3National Medical Care, Medical Products Div., Inc.1990-03-22640
K900243DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6National Medical Care, Medical Products Div., Inc.1990-03-22640
K900323PERITONEAL DIALYSIS CYCLER SETNational Medical Care, Medical Products Div., Inc.1990-03-22580
K900005DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1National Medical Care, Medical Products Div., Inc.1990-03-02590
K896956QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3National Medical Care, Medical Products Div., Inc.1990-02-27750
K900004CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3National Medical Care, Medical Products Div., Inc.1990-02-27560
K900006CATHETER ADAPTER SEALING CAP NO. 48-1028-9National Medical Care, Medical Products Div., Inc.1990-02-27560
K896761TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1National Medical Care, Medical Products Div., Inc.1990-02-26870
K896763CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1National Medical Care, Medical Products Div., Inc.1990-02-26870
K896764UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5National Medical Care, Medical Products Div., Inc.1990-02-26870
K895244MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.National Medical Care, Medical Products Div., Inc.1990-02-121750
K895759HOLLOW FIBER DIALYZER SERIES FOCUS 160/160HNational Medical Care, Medical Products Div., Inc.1989-11-08430
K894637NATIONAL MEDICAL CARE VENOUS LINE 03-9548National Medical Care, Medical Products Div., Inc.1989-09-22600
K893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.1989-07-24750
K893677HOLLOW FIBER DIALYZER FOCUS 70HNational Medical Care, Medical Products Div., Inc.1989-07-24690
K892870PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLDNational Medical Care, Medical Products Div., Inc.1989-05-18290
K892871PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLDNational Medical Care, Medical Products Div., Inc.1989-05-18290
K892872PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLDNational Medical Care, Medical Products Div., Inc.1989-05-18290
K883408NATURALYTE MIXERNational Medical Care, Medical Products Div., Inc.1988-10-31810
K883490ACCUFLO UF CONTROL MODULE NO. 74-0100-3National Medical Care, Medical Products Div., Inc.1988-09-29440
K870722LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINENational Medical Care, Medical Products Div., Inc.1988-09-145870

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