Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IKN — Predicate Candidate Screening
75 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
307 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | 2017-12-19 | 98 | 0 |
| K163150 | ViMove2 | Dorsavi, Ltd. | 2017-07-14 | 247 | 0 |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017-03-01 | 188 | 0 |
| K142494 | ViMove | Dorsavi, Ltd. | 2015-05-28 | 265 | 0 |
| K131094 | VIMOVE | Dorsa VI Pty., Ltd. | 2014-07-11 | 449 | 0 |
| K123902 | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | Oktx, LLC | 2013-09-13 | 269 | 0 |
| K123399 | MYOVISION 3.0 WIREFREE SYSTEM | Precision Biometrics, Inc. | 2013-08-01 | 269 | 0 |
| K113074 | CMAP PRO | Medical Technologies, Inc. | 2012-02-02 | 108 | 0 |
| K102610 | FOCUS EMG DEVICE | Teleemg, LLC USA | 2011-03-04 | 175 | 0 |
| K110048 | CERSR ELECTROMYOGRAPHY SYSTEM | Spinematrix, Inc. | 2011-01-26 | 20 | 0 |
| K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | Uroval | 2009-09-11 | 274 | 0 |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | Eb Neuro S.P.A. | 2008-05-23 | 171 | 0 |
| K063447 | INSIGHT DISCOVERY | Fasstech | 2007-08-16 | 274 | 0 |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | 2005-10-28 | 85 | 0 |
| K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER | Medical Technologies Unlimited, Inc. | 2004-01-07 | 194 | 0 |
| K033452 | CWAS 1000 | Fasstech | 2003-11-28 | 29 | 0 |
| K023209 | INSIGHT MILLENNIUM III | Fasstech | 2003-10-10 | 379 | 0 |
| K024316 | NIM-PRS | Medtronic Xomed, Inc. | 2003-01-06 | 11 | 0 |
| K023147 | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MO | Bortec Biomedical, Ltd. | 2002-12-12 | 83 | 0 |
| K022719 | PHYSICAL MONITORING REGISTRATION UNIT | Maryrose Cusimano, Ph.D./Phil Reaston | 2002-11-13 | 90 | 0 |
| K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | Nihon Kohden America, Inc. | 2001-06-28 | 121 | 0 |
| K002104 | COMBINED PHYSIOLOGICAL MONITORING SYSTEM | Maryrose Cusimano, Ph.D. & Scott Zeff | 2000-10-10 | 90 | 0 |
| K001800 | ACCUWARM EMG HEAT LAMP | Rjl Associates, LLC | 2000-09-12 | 90 | 0 |
| K001562 | NEURO SCAN MEDICAL SYSTEMS A4000 | Neuro Scan Labs | 2000-08-16 | 89 | 0 |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) | Neurosoft, Inc. | 2000-05-17 | 65 | 0 |
| K000220 | MA-300 ELECTROMYOGRAPHY SYSTEM | Motion Lab Systems, Inc. | 2000-02-24 | 31 | 0 |
| K993878 | JE 2000 | Jack'S Electrodes | 2000-02-01 | 78 | 0 |
| K990766 | CERSR ELECTROMYOGRAPHY SYSTEM | Paraspinal Diagnostic Corp. | 1999-08-27 | 172 | 1 |
| K984052 | SYNERGY IOM SYSTEM | Oxford Instruments Medical Systems | 1999-05-17 | 185 | 0 |
| K972419 | TOENNIES NEUROSCREEN SYSTEM | Erich Jaeger, Inc. | 1998-04-30 | 307 | 0 |
| K974385 | MLS ELECTROMYOGRAPHIC PREAMPLIFIER | Motion Lab Systems, Inc. | 1998-02-19 | 90 | 0 |
| K974010 | ADVANTAGE EMG SYSTEM, MODEL #A100 | Advantage Medical Division of Cme Telemetrix | 1998-01-16 | 87 | 0 |
| K973355 | ADVANTAGE 3000 | Advantage Medical Division of Cme Telemetrix | 1997-12-05 | 88 | 0 |
| K941144 | EXCEL EMG | Excel Tech. , Ltd. | 1995-11-07 | 607 | 0 |
| K942965 | COMPUTER DYNO/GONIO/MYO GRAPHY | Infotronic Medical Engineering | 1995-10-07 | 470 | 0 |
| K952655 | B & L ELECTRODE | B & L Engineering | 1995-09-28 | 143 | 0 |
| K944787 | INTEGRATED MOVEMENT ANALYZER | Maryrose | 1995-07-07 | 282 | 0 |
| K935368 | STC DIAGNOSTIC 8000 | Sherman Technology Corp. | 1995-05-01 | 543 | 0 |
| K930328 | NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT | Bio-Logic Systems Corp. | 1993-07-02 | 161 | 0 |
| K922488 | PHASIS ELECTROMYOGRAPH | Biosound, Inc. | 1993-03-02 | 279 | 0 |
| K911388 | CAVOMAT | Wiest USA, Inc. | 1991-12-04 | 250 | 0 |
| K901732 | EMG ACCESSORY FOR POSTUROGRAPHY | Neurocom International, Inc. | 1991-09-10 | 511 | 0 |
| K912071 | SPACE(TM) 7500 | F.M. Wiest USA, Inc. | 1991-07-09 | 60 | 0 |
| K893130 | EMG NAVIGATOR & EMG TRAVELER | Bio-Logic Systems Corp. | 1990-03-20 | 329 | 0 |
| K883781 | NICOLET NEUROPORT/ACE SYSTEM | Nicolet Instrument Corp. | 1989-06-05 | 272 | 0 |
| K890495 | NICOLET VIKING II SYSTEM | Nicolet Instrument Corp. | 1989-03-16 | 43 | 0 |
| K880977 | ADR-2000 AMBULATORY DATA RECORDING SYSTEM | Aaron Laboratories, Inc. | 1988-04-13 | 36 | 0 |
| K880976 | AL-200B MUSCLE ACTIVITY INTEGRATOR | Aaron Laboratories, Inc. | 1988-04-13 | 36 | 0 |
| K880573 | MODIFIED NICOLET VIKING SYSTEM | Nicolet Biomedical Instruments | 1988-03-22 | 41 | 0 |
| K872836 | SPINOSCOPE | Diagnospine Fabrication, Inc. | 1987-09-29 | 74 | 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