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

Djo, LLC — Predicate Candidate Screening

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

113 daysmedian FDA review time

163 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201653	Compex Sport Elite 3.0	Djo, LLC	2020-11-27	162	0
K170918	Compex Sport Elite	Djo, LLC	2017-06-20	83	0
K170903	Compex Wireless USA	Djo, LLC	2017-06-19	83	0
K153704	Strive	Djo, LLC	2016-06-03	163	0
K153696	Chattanooga Revolution Wireless	Djo, LLC	2016-04-14	113	0
K153224	VitalStim(R) Plus Electrotherapy System	Djo, LLC	2016-02-17	103	0
K143551	Compex Wireless USA	Djo, LLC	2015-04-28	134	0
K132284	VECTRA NEO CLINICAL THERAPY SYSTEM	Djo, LLC	2014-04-10	261	0
K130722	AIRCAST VENAFLOW ELITE SYSTEM	Djo, LLC	2013-06-20	94	0
K124016	EMPI PHOENIX	Djo, LLC	2013-05-06	130	0
K122499	AIRCAST VENAFLOW ELITE SYSTEM	Djo, LLC	2012-10-18	63	0
K091700	AIRCAST VENAFLOW ELITE SYSTEM	Djo, LLC	2009-07-09	29	1

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