Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DXG — Predicate Candidate Screening
177 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
286 days90th percentile
177clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | 2026-02-13 | 143 | 0 |
| K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | 2025-09-26 | 155 | 0 |
| K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | 2023-12-20 | 163 | 0 |
| K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | 2021-11-23 | 104 | 0 |
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | 2020-04-30 | 265 | 0 |
| K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019-12-17 | 29 | 0 |
| K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | 2019-11-27 | 230 | 0 |
| K181372 | Argos | Retia Medical, LLC | 2018-12-13 | 204 | 0 |
| K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | 2018-01-18 | 175 | 0 |
| K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | 2017-06-05 | 189 | 0 |
| K152935 | LiDCOunity Monitor | Lidco, Ltd. | 2016-03-17 | 164 | 0 |
| K134051 | TRANSONIC ELSA SYSTEM | Transonic Systems, Inc. | 2015-01-29 | 394 | 0 |
| K134035 | TRANSONIC HCM 103 SYSTEM | Transonic Systems, Inc. | 2014-09-17 | 260 | 0 |
| K140017 | TRANSONIC HCM 102 SYSTEM | Transonic Systems, Inc. | 2014-09-16 | 257 | 0 |
| K132892 | TEBCO-W | Bomed, Inc. | 2014-08-01 | 319 | 0 |
| K131892 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences, LLC | 2014-05-22 | 331 | 0 |
| K131588 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; V | Edwards Lifesciences, LLC | 2014-05-22 | 356 | 0 |
| K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | 2014-01-16 | 157 | 0 |
| K122400 | CARDIOX FLOW DETECTION SYSTEM | Cardiox Corp. | 2013-11-05 | 455 | 0 |
| K131048 | LIDCO CNAP MODULE | Lidco, Ltd. | 2013-08-28 | 135 | 0 |
| K122247 | LIDCORAPID V2 MONITOR | Lidco, Ltd. | 2013-03-20 | 236 | 0 |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Transonic Systems, Inc. | 2012-09-07 | 255 | 0 |
| K122121 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE | Pulsion Medical Systems SE | 2012-08-02 | 16 | 0 |
| K112448 | PULSIOFLEX | Pulsion Medical Systems, Inc. | 2011-09-22 | 28 | 0 |
| K110597 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences | 2011-06-14 | 104 | 0 |
| K103094 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; | Edwards Lifesciences, LLC | 2011-05-17 | 210 | 0 |
| K100709 | EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010-12-07 | 270 | 0 |
| K101487 | CHEETAH NICOM SYSTEM | Cheetah Medical, Inc. | 2010-07-02 | 35 | 0 |
| K091786 | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX | Pulsion Medical Systems AG | 2010-06-18 | 366 | 0 |
| K092219 | NAVIGATOR CLINICAL GUIDENCE SYSTEM | Applied Physiology Pty , Ltd. | 2010-05-12 | 294 | 0 |
| K082308 | MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXI | Edwards Lifesciences, LLC | 2008-12-09 | 118 | 0 |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Transonic Systems, Inc. | 2008-09-08 | 236 | 1 |
| K081776 | CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM | Omega Critical Care Limited | 2008-07-22 | 29 | 0 |
| K071631 | NICOM ELECTRODES | Cheetah Medical, Inc. | 2008-01-18 | 218 | 0 |
| K073113 | INFINITY PICCO POD, MODEL MS16734 | Draeger Medical Systems, Inc. | 2008-01-03 | 59 | 0 |
| K072735 | PULSION PICCO-2, MODEL 8500 | Pulsion Medical Systems AG | 2007-10-18 | 21 | 0 |
| K062134 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2006-08-22 | 27 | 0 |
| K060898 | PULSION PICCO PLUS, MODEL 8100 | Pulsion Medical Systems AG | 2006-07-25 | 113 | 0 |
| K060660 | EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESE | Edwards Lifesciences, LLC | 2006-04-25 | 43 | 1 |
| K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC M | Edwards Lifesciences, LLC | 2004-12-09 | 30 | 2 |
| K042144 | NICOM | Cheetah Medical, Inc. | 2004-11-12 | 95 | 0 |
| K040287 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END | Edwards Lifesciences, LLC | 2004-04-26 | 80 | 0 |
| K032997 | MODIFICATION TO: HORIZON 9000WS | Mennen Medical , Ltd. | 2003-10-15 | 20 | 0 |
| K023960 | LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 | Lidco, Ltd. | 2003-01-09 | 41 | 0 |
| K021874 | ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST | Abbott Laboratories | 2002-07-12 | 35 | 0 |
| K010049 | PULSECO HEMODYNAMIC MONITOR CM71 | Lidco, Ltd. | 2001-06-14 | 160 | 0 |
| K000664 | VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS | Baxter Healthcare Corp | 2000-09-20 | 205 | 0 |
| K001762 | PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYST | Pulsion Medical Systems, Inc. | 2000-06-13 | 4 | 0 |
| K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HO | Mennen Medical, Inc. | 1999-06-24 | 30 | 0 |
| K962918 | LIDCO SYSTEM | Lidco, Ltd. | 1999-01-08 | 925 | 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