Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Neurometrix, Inc. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

126 daysmedian FDA review time

255 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
DEN210046	Quell-FM	Neurometrix, Inc.	2022-05-18	225
K152954	Quell	Neurometrix, Inc.	2016-01-05	90
K140586	ASCEND ELECTRODE	Neurometrix, Inc.	2014-11-17	255
K140333	ASCEND	Neurometrix, Inc.	2014-07-03	143
K130919	SENSUS	Neurometrix, Inc.	2013-07-02	90
K121816	SENSUS ELECTRODE	Neurometrix, Inc.	2012-11-26	159
K121184	SENSUS	Neurometrix, Inc.	2012-08-02	106
K091155	ASCEND	Neurometrix, Inc.	2009-09-03	135
K083322	NEUROMETRIX BIOAMPLIFIER	Neurometrix, Inc.	2009-05-27	196
K083818	UNIVERSAL ELECTRODES	Neurometrix, Inc.	2009-01-21	30
K081871	UNIVERSAL ELECTRODES	Neurometrix, Inc.	2008-09-29	90
K070109	NEUROMETRIX ADVANCE	Neurometrix, Inc.	2008-04-25	470
K060584	NC-STAT	Neurometrix, Inc.	2006-07-31	146
K041320	MODIFICATION TO NC-STAT	Neurometrix, Inc.	2004-08-12	86
K013459	MODIFICATION OF NC-STAT	Neurometrix, Inc.	2002-01-17	91
K003508	NC-STAT	Neurometrix, Inc.	2001-01-17	64
K000565	MODIFICATION TO NC-STAT	Neurometrix, Inc.	2000-06-27	126
K982359	NC-STAT	Neurometrix, Inc.	1998-10-02	88

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