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

LXM — Predicate Candidate Screening

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

160 daysmedian FDA review time

349 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K234036	SONIK MONARK 100	Neuro Spinal Innovation, Inc.	2024-02-15	56	0
K192629	Spinalytics	Optima Health Solutions International Corp.	2019-12-21	89	0
K172536	Atlas Percussion Adjusting Instrument	Spinalight, Inc.	2018-06-20	302	0
K160278	VSTAAR AdjusteR	Spinal Acoustics, LLC	2016-11-04	276	0
K130666	KHAN KINETIC TREATMENT (KKT-M2)	Optima Health Solutions International Corporation	2014-01-23	317	0
K112606	ACTIVATOR V-E	Activator Methods International, Ltd.	2012-03-06	180	0
K082218	MAX ADJUSTING INSTRUMENT	Manna Omni International, Inc.	2008-08-13	7	0
K080261	IMPULSE IQ ADJUSTING INSTRUMENT	Neuromechanical Innovations, LLC	2008-04-11	70	0
K072519	ACTIVATOR V SPINAL ADJUSTING INSTRUMENT	Activator Methods International, Ltd.	2007-10-23	46	0
K060043	KHAN KINETIC TREATMENT DEVICE (KKT-M1)	Optima Health Solutions International, Inc.	2006-03-23	76	0
K050428	TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR	Advanced Spinal Technologies, Inc.	2005-06-14	116	0
K023462	IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUR	Neuromechanical Innovations, LLC	2003-01-13	90	0
K021238	FRYE ADJUSTING INSTRUMENT	Frye Health Systems	2002-10-09	174	0
K010851	HARRISON HAND HELD ADJUSTING INSTRUMENT	Harrison Cbp Seminars	2001-09-18	181	0
K003185	FS ACTIVATOR III	Activator Methods International, Ltd.	2001-03-20	160	0
K001476	TORQUE INSTRUMENT, MODEL 8500	Spinalight, Inc.	2000-08-04	85	0
K973914	SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR	Sense Technology, Inc.	1998-06-30	259	0
K974376	JTECH ADJUSTER REFLEX GUN	J-Tech Medical, Inc.	1998-02-18	90	0
K973506	ACTIVATOR II	Activator Methods, Inc.	1998-01-27	133	0
K962239	SMART ADJUSTER (SA201)	Sigma	1997-01-10	213	0
K950646	INTEGRATOR	Moyco Union Broach, Div., Moyco Technologies, Inc.	1996-04-30	442	0
K955540	HAND HELD ATLAS INSTRUMENT	Spinalight, Inc.	1996-03-04	90	0
K951217	ATLAS ORTHOGONAL PERCUSSION INSTTUMENT	Sweat Chiropractic Clinic	1995-11-21	249	0
K946258	MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT	Spinalight, Inc.	1995-11-20	349	1
K944369	NEW-STIM SPINAL ADJUSTMENT INSTRUMENT	Lawrence E. Newsum, DC	1995-04-26	231	0
K940085	FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01	Sense Technology, Inc.	1994-12-07	334	0
K930431	ARTHROSTIM MANIPULATOR	Freeman Procedure Seminars	1994-07-15	535	0
K922693	KINETIC TECHNOOGY PRECISION ADJUSTOR MODEL SHLCP-1	Kinetic Technology, Inc.	1992-09-30	118	0
K922694	KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4	Kinetic Technology, Inc.	1992-09-30	118	0
K922692	KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR	Kinetic Technology, Inc.	1992-09-30	118	0
K922695	KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5	Kinetic Technology, Inc.	1992-09-30	118	1
K870910	PRECISION SPINAL ADJUSTER MODEL 115	Kinetic Technology, Inc.	1988-04-26	418	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