Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DYG — Predicate Candidate Screening
99 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
220 days90th percentile
99clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR | Edwards Lifesciences | 2024-12-09 | 115 | 0 |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Paci | Edwards Lifesciences | 2024-06-27 | 192 | 1 |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | 2024-06-06 | 188 | 1 |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuff | Edwards Lifesciencess, LLC | 2023-09-21 | 143 | 2 |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022-12-09 | 144 | 0 |
| K193466 | Swan-Ganz Catheters | Edwards Lifesciences, LLC | 2020-02-16 | 62 | 0 |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016-05-03 | 109 | 4 |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | 2011-07-14 | 560 | 0 |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | Oscor, Inc. | 2008-06-18 | 65 | 0 |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOF | Transonic Systems, Inc. | 2002-03-19 | 417 | 0 |
| K012225 | ATTAIN 6215 VENOGRAM BALLOON CATHETER | Medtronic Vascular | 2001-08-28 | 43 | 0 |
| K003118 | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MOD | Zcv ,Inc. | 2000-12-20 | 76 | 0 |
| K001063 | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MO | Baxter Healthcare Corp | 2000-07-07 | 95 | 0 |
| K993245 | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TR | Alba Critical Care, Ltd. | 1999-10-28 | 30 | 0 |
| K963336 | HARMAC THERMODILUTION CATHETER | Harmac Medical Products, Inc. | 1997-08-14 | 412 | 0 |
| K955816 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONI | Baxter Healthcare Corp | 1997-05-06 | 497 | 1 |
| K963248 | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575- | J-Lloyd Medical, Inc. | 1997-02-03 | 168 | 0 |
| K961999 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1996-11-19 | 181 | 0 |
| K951566 | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSIO | Baxter Healthcare Corp | 1995-11-27 | 237 | 0 |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | J-Lloyd Medical, Inc. | 1994-08-11 | 185 | 0 |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | Baxter Edwards | 1994-05-24 | 91 | 2 |
| K935404 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1994-05-03 | 175 | 0 |
| K934742 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT | Baxter Healthcare Corp | 1994-01-24 | 112 | 2 |
| K924452 | SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER | Baxter Healthcare Corp | 1993-10-29 | 422 | 2 |
| K925444 | CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR | Ami-Med Corp. | 1993-07-19 | 264 | 0 |
| K920869 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1993-01-13 | 323 | 0 |
| K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER | Intec Medical, Inc. | 1991-06-03 | 39 | 0 |
| K901287 | INTHERM TEMPORARY OCCLUSION CATHETER | Interventional Therapeutics Corp. | 1991-02-20 | 337 | 0 |
| K904287 | STEALTH DILATION CATHETER SYSTEM/MODIFICATION | Target Therapeutics | 1991-01-16 | 124 | 0 |
| K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES | Intec Medical, Inc. | 1990-07-31 | 138 | 0 |
| K900879 | SOFT-WEDGE(TM) SYRINGE | Baxter Healthcare Corp | 1990-05-10 | 73 | 0 |
| K896466 | SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME | Baxter Healthcare Corp | 1990-02-08 | 87 | 0 |
| K892530 | CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH | Arrow Intl., Inc. | 1989-09-26 | 168 | 1 |
| K893435 | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER | Cathlab Corp. | 1989-09-26 | 147 | 0 |
| K893474 | BARD CATH LAB THERMODILUTION CATHETER | C.R. Bard, Inc. | 1989-09-05 | 124 | 0 |
| K883948 | MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER | NuMED, Inc. | 1989-04-21 | 220 | 0 |
| K874465 | SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD | Abbott Laboratories | 1988-05-25 | 208 | 0 |
| K874117 | MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE | Medtronic Vascular | 1987-11-05 | 27 | 0 |
| K872770 | DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. | Nova Medical Specialties | 1987-10-15 | 93 | 0 |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | Parke-Davis Co. | 1986-08-29 | 87 | 0 |
| K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | Webster Laboratories, Inc. | 1985-12-03 | 113 | 0 |
| K852294 | BARD-PARKER OCCLUSION BALLOON CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-09-17 | 111 | 0 |
| K850952 | BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI | C.R. Bard, Inc. | 1985-08-05 | 151 | 0 |
| K851948 | MEDTRONIC MODEL 6404 | Medtronic Vascular | 1985-06-20 | 48 | 0 |
| K843409 | FLOW-DIRECTED THERMODILUTION CATH | Andover Medical, Inc. | 1984-10-18 | 48 | 0 |
| K843411 | THERMAL DILUTION CATHETER | Andover Medical, Inc. | 1984-10-18 | 48 | 0 |
| K841639 | NOVA BALLOON THERMODILUTION CATH. | Nova Medical Specialties | 1984-08-12 | 114 | 20 |
| K841640 | NOVA BALLOON THERMODILUTION INFUSION | Nova Medical Specialties | 1984-08-12 | 114 | 0 |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | Waters Instruments, Inc. | 1984-07-13 | 67 | 0 |
| K841705 | WEDGE PRESSURE CATHETER FLOW DIRECTED | Mansfield Scientific, Inc. | 1984-07-13 | 81 | 0 |
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