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

ILX — Predicate Candidate Screening

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

165 daysmedian FDA review time

332 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241395	Active System; Avenue8	Caerus Corporation	2024-12-18	216	0
K202337	Pulsed electromagnetic field wrap	Hi-Dow International, Inc.	2020-12-15	120	0
K190251	RecoveryRx	Bioelectronics Corporation	2019-06-28	141	0
K131979	PROVANT THERAPY SYSTEM	Regenesis Biomedical, Inc.	2013-12-13	168	0
K121702	ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE	Orthocor Medical	2013-05-06	332	0
K121338	ZEOBI	Ivivi Health Science, LLC	2012-07-27	85	0
K091791	PROVANT SYSTEM, MODEL 4201	Regenesis Biomedical, Inc.	2010-04-07	294	0
K092044	ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE	Orthocor Medical	2009-12-18	165	0
K091996	ORTHOCOR KNEE SYSTEM BASIC	Orthocor Medical	2009-12-15	166	0
K070541	IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II	Ivivi Technologies, Inc.	2008-12-11	654	0
K070931	MODEL PMT850	Promedtek, Inc.	2007-05-24	51	0
K022404	ACTIBAND	Paw, LLC	2002-08-08	16	0
K972093	REGENESIS MODEL 42	Regenesis Biomedical, Inc.	1997-10-21	139	1
K903675	MAGNETIC RESONANCE THERAPY DEVICE	Mrt, Inc.	1991-01-17	157	0
K882816	PULSAR EM	Apex Medical, Inc.	1989-04-27	293	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