Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXJ — Predicate Candidate Screening
78 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
300 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | 2021-11-10 | 135 | 0 |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 | 77 | 0 |
| K201162 | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 | 119 | 0 |
| K173107 | Vios Central Station Monitor Software, Vios Central Server S | Vios Medical, Inc. | 2018-07-26 | 300 | 0 |
| K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018-07-16 | 138 | 0 |
| K173381 | Nexxis OR | Barco N.V. | 2018-02-22 | 115 | 3 |
| K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 | 122 | 0 |
| K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017-06-08 | 113 | 0 |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | 2017-04-21 | 57 | 0 |
| K161880 | NIVR58-T kit | Barco N.V. | 2017-03-14 | 249 | 0 |
| K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 | 214 | 0 |
| K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016-09-15 | 56 | 5 |
| K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips Medical Systems | 2015-10-30 | 162 | 0 |
| K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015-10-21 | 117 | 0 |
| K133994 | SIVR56-T KIT | Barco N.V. | 2014-12-01 | 340 | 0 |
| K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | Ge Medical Systems Information Technologies, Inc. | 2014-04-30 | 131 | 0 |
| K132488 | ZOLL CODE WRITER | ZOLL Medical Corporation | 2014-04-03 | 238 | 0 |
| K131272 | SIREN EPCR SUITE | Medusa Medical Technologies, Inc. | 2014-01-03 | 245 | 0 |
| K131919 | ZOLL EPCR IOS | ZOLL Medical Corporation | 2013-12-17 | 174 | 0 |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | Sorin Group Deutschland GmbH | 2013-07-23 | 33 | 0 |
| K122167 | NEXXIS OR | Barco N.V. | 2013-04-22 | 273 | 0 |
| K113214 | TLINK DATA MANAGEMENT SYSTEM (DMS) | Terumo Cardiovascular Systems Corp. | 2012-02-07 | 99 | 0 |
| K111905 | INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP0 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-10-04 | 91 | 0 |
| K112645 | RADIFORCE LARGE MONITOR SYSTEM | Eizo GmbH | 2011-09-22 | 10 | 0 |
| K103473 | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR | ZOLL Medical Corporation | 2011-05-13 | 170 | 0 |
| K110085 | VANTAGE VIEW SYSTEM | St Jude Medical | 2011-01-26 | 15 | 0 |
| K101474 | MD VISION SYSTEM | Perkins Healthcare Technologies | 2010-07-02 | 35 | 0 |
| K100272 | INTELLIVUE CLINICAL INFORMATION PORTFOLIO | Philips Medical Systems | 2010-04-14 | 75 | 2 |
| K083321 | CARDIO-VIEW | Curlview Igt, LLC | 2008-11-26 | 15 | 0 |
| K073372 | ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) | Systemsone | 2007-12-07 | 4 | 0 |
| K053356 | MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL | Ge Medical Systems Information Technologies | 2006-04-19 | 138 | 1 |
| K013515 | INFINITY EXPLORER | Siemens Medical Solutions USA, Inc. | 2002-01-10 | 80 | 0 |
| K001112 | GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC | General Electric Medical Systems Information Techn | 2000-06-14 | 69 | 0 |
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | Hewlett-Packard Co. | 1999-08-31 | 25 | 8 |
| K942685 | ECG REVIEW STATION | Mortara Instrument, Inc. | 1997-08-12 | 1162 | 0 |
| K962811 | SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION | Spacelabs Medical, Inc. | 1997-06-24 | 341 | 0 |
| K945277 | HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICA | Hewlett-Packard Co. | 1995-01-30 | 94 | 0 |
| K934093 | 580CDR DISPLAY DRIVER | Vidco, Inc. | 1994-08-18 | 360 | 0 |
| K932894 | 620CSR DISPLAY DRIVER | Vidco, Inc. | 1994-06-20 | 371 | 0 |
| K926219 | 516YT DISPLAY DRIVER | Vidco, Inc. | 1993-12-16 | 371 | 0 |
| K926162 | 580CD DISPLAY DRIVER | Vidco, Inc. | 1993-11-08 | 335 | 0 |
| K932724 | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY | Spacelabs Medical, Inc. | 1993-11-05 | 151 | 4 |
| K905788 | MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM | Hewlett-Packard Co. | 1991-06-06 | 161 | 0 |
| K901072 | CENTRALSCOPE 12 | Marquette Electronics, Inc. | 1990-08-23 | 169 | 0 |
| K902334 | MONITOR, MODEL 2817 | Esaote Biomedica Spa | 1990-06-26 | 33 | 0 |
| K901884 | 7620 REMOTE CENTRAL STATION REPEATER | Marquette Electronics, Inc. | 1990-06-12 | 47 | 0 |
| K884423 | HORIZON DISPLAY CONTROLLER PART # 266-200-010 | Mennen Medical, Inc. | 1989-05-31 | 224 | 0 |
| K890353 | SMDS460 SURGICAL MONITOR DISPLAY SYSTEM | Vidco, Inc. | 1989-03-02 | 37 | 0 |
| K883973 | MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A | Nihon Kohden America, Inc. | 1988-11-09 | 50 | 0 |
| K883031 | Q-CATH RM | Quinton, Inc. | 1988-09-20 | 63 | 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