Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JXE — Predicate Candidate Screening

27 FDA 510(k) clearances under this product code; the 50 most recent screened below.

99 daysmedian FDA review time

332 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K240189	NM-01/CPT neurometer (NM-01/CPT)	Mde Orvosbiológiai Kutató, Fejleszto,	2025-03-26	427
K190536	Mediracer NCS	Mediracer OY	2019-09-25	205
K070109	NEUROMETRIX ADVANCE	Neurometrix, Inc.	2008-04-25	470
K060584	NC-STAT	Neurometrix, Inc.	2006-07-31	146
K053058	XLTEK NEUROPATH, MODEL PK1070	Excel Tech. , Ltd.	2006-02-07	99
K052904	VIRTUAL MEDICAL SYSTEMS MODEL VT3000	Scientific Imaging, Inc.	2005-10-27	13
K041320	MODIFICATION TO NC-STAT	Neurometrix, Inc.	2004-08-12	86
K013459	MODIFICATION OF NC-STAT	Neurometrix, Inc.	2002-01-17	91
K012069	MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT	Neurotron Medical, Inc.	2001-08-01	30
K003508	NC-STAT	Neurometrix, Inc.	2001-01-17	64
K001692	NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8	Neurosoft, Inc.	2000-11-24	175
K000565	MODIFICATION TO NC-STAT	Neurometrix, Inc.	2000-06-27	126
K982359	NC-STAT	Neurometrix, Inc.	1998-10-02	88
K963208	NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)	Neurotron Medical	1997-07-14	332
K935298	INSTA-NERVE(TM) NERVE CONDUCTION MONITOR	Insta Nerve Canada, Inc.	1994-08-03	274
K935017	TD50 ELECTROMYOGRAPH	Medelec Intl. Corp.	1994-07-28	282
K932533	SMARTSCOPE	Insight Medical Corp.	1994-03-31	309
K923665	REUSABLE DUAL DISC BAR RECORDING ELECTRODES	Chalgren Enterprises, Inc.	1992-10-05	75
K921504	REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS	Chalgren Enterprises, Inc.	1992-09-11	164
K904165	SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT	Occupational Preventive Diagnostics, Inc.	1991-05-28	259
K900378	EMG OPTION FOR MICROSHEV 4000	Micro-Shev , Ltd.	1990-04-10	74
K884663	IMPULSE EPIDURAL ELECTRODE	Impulse Systems, Inc.	1989-01-17	71
K843924	DIGITAL ELECTRONEUROMETER S-100	Neurotron, Inc.	1985-03-12	158
K844681	EMG REPORT GENERATOR	Microsystem Controls	1985-02-26	88
K844216	GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR	Grass Instrument Co.	1985-01-18	79
K820031	CADWELL 5200	Cadwell Laboratories, Inc.	1982-02-04	29
K760689	NERVEL-NERVE CONDUCTION VELOCITY METER	Bak Electronics	1976-10-05	14

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