Atlas FDA

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

Research Medical, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
245 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970739RMI HEMOCONCENTRATOR PREFERENCE PACKResearch Medical, Inc.1997-07-081300
K964833RMI DUAL FLUID IRRIGATING SYRINGEResearch Medical, Inc.1997-02-19790
K961927RMI HEMOCONCENTRACTOR TUBING SETResearch Medical, Inc.1996-08-13880
K960098RMI INTERNAL MAMMARY ARTERY CANNULAResearch Medical, Inc.1996-03-26750
K951344RMI HEMOCONCENTRATORResearch Medical, Inc.1995-08-151440
K922083RMI SURGICCAL SITE VISUALIZATION WANDResearch Medical, Inc.1993-01-292700
K920936RMI EXTERNAL CORONARY ARTERY OCCLUDERResearch Medical, Inc.1992-12-182940
K915869RMI NORMOCLUDER CORONARY ARTERY OCCLUDERResearch Medical, Inc.1992-12-083430
K920676RMI SOFCLAMPResearch Medical, Inc.1992-04-15610
K910221RMI VASCULAR TOURNIQUET KITResearch Medical, Inc.1991-05-161190
K901231RMI CARDIOPLEGIA DELIVERY KITSResearch Medical, Inc.1990-06-08860
K897137RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORINGResearch Medical, Inc.1990-03-27900
K896777RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINEResearch Medical, Inc.1990-02-27880
K896778RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVEResearch Medical, Inc.1990-02-27880
K896636RMI ANTEPLEGIA CANNULAResearch Medical, Inc.1990-02-15850
K892368RMI CARDIOPLEGIA DELIVERY SETSResearch Medical, Inc.1989-12-072450
K892377RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SETResearch Medical, Inc.1989-12-072452
K891576FEM-FLEX FEMORAL ACCESS CANNULATION SETResearch Medical, Inc.1989-10-122062
K894243RMI ARTERIAL PERFUSION CANNULAResearch Medical, Inc.1989-09-19900
K880103CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.Research Medical, Inc.1988-03-22700
K870421TDMAC-HEPARIN COATED RMIResearch Medical, Inc.1987-05-221080
K870109RMI VENOUS DRAINAGE CANNULAResearch Medical, Inc.1987-03-16630
K870507GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULAResearch Medical, Inc.1987-03-16390
K863740RMI FEMORAL VENOUS DRAINAGE CANNULAResearch Medical, Inc.1987-02-191490
K862634TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNTResearch Medical, Inc.1986-10-311130
K861790RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNTResearch Medical, Inc.1986-07-21730
K861322RMI POROUS VENT PLUGResearch Medical, Inc.1986-05-30520
K860988RMI CAROTID BY-PASS SHUNTResearch Medical, Inc.1986-05-21650
K854812NELSON-JUNG PLEURAL CATHResearch Medical, Inc.1986-02-11700
K852197LAP-CATHResearch Medical, Inc.1985-11-061700
K852456FAP-CATHResearch Medical, Inc.1985-11-011440
K850785FASTUBE NERVE REGENERATION DEVICEResearch Medical, Inc.1985-07-101340
K843423PHYSIO GAS ANALYZERResearch Medical, Inc.1985-02-261790
K841425JINOTTI OXYGEN/SUCTION CATHETERResearch Medical, Inc.1984-09-131600
K841727UROLOGICAL CATHETER & ACCESSORIESResearch Medical, Inc.1984-06-07430

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