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

Axon Systems, Inc. — Predicate Candidate Screening

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

103 daysmedian FDA review time

142 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K090838	STIMULUS/DISSECTION INSTRUMENTS	Axon Systems, Inc.	2009-07-20	115
K062996	DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES	Axon Systems, Inc.	2007-01-12	102
K062198	SUNSPOTS PRE-GELLED SURFACE ELECTRODES	Axon Systems, Inc.	2006-12-19	140
K061639	ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL	Axon Systems, Inc.	2006-11-01	142
K061113	ORTHOMON	Axon Systems, Inc.	2006-05-23	32
K050798	ECLIPSE NEUROLOGICAL WORKSTATION	Axon Systems, Inc.	2005-08-15	139
K050194	AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES	Axon Systems, Inc.	2005-04-26	89
K032741	EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL W	Axon Systems, Inc.	2003-12-16	103
K022785	EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICA	Axon Systems, Inc.	2002-10-09	48
K010697	UNIQUE AMBULATORY EEG	Axon Systems, Inc.	2001-06-06	90
K002316	PHOENIX DIGITAL EEG	Axon Systems, Inc.	2000-10-26	87
K971819	EPOCH 2000 NEUROLOGICAL WORKSTATION	Axon Systems, Inc.	1997-11-20	188
K955257	SS102 DUAL CHANNEL SEP STIMULATOR	Axon Systems, Inc.	1996-02-02	87
K900482	SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG	Axon Systems, Inc.	1990-06-20	139
K863193	SENTINEL 4 EEG ANALYZER	Axon Systems, Inc.	1986-12-02	105

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