Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LBB — Predicate Candidate Screening

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

90 daysmedian FDA review time

236 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K162412	Hoggan Scientific® microFET2™	Hoggan Scientific, LLC	2017-03-09	192
K073154	FACTS HAND AND PINCH GRIP COMBO	Global Services Group, LLC	2008-02-14	98
K052309	DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE,	Saehan Corp.	2005-09-27	34
K042889	DYNAMOMETER - MODEL FCE AND MODEL MSC	Ametek	2004-11-16	28
K012492	KADANCE 2000	Kada Research, Inc.	2001-11-02	91
K981730	DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002	Nk Biotechnical Corp.	1998-07-17	63
K980363	ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)	Orofacial Dynamics	1998-04-16	77
K964933	MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)	Mekanika, Inc.	1997-02-03	55
K964685	DYNAMOMETER	John Chatillon & Sons, Inc.	1997-01-27	66
K935757	GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM	Greenleaf Medical Systems, Inc.	1994-04-15	140
K931321	CSD 200/300/400/500 DYNAMOMETER	John Chatillon & Sons, Inc.	1994-02-15	336
K923965	NK GRASP SENSOR, MODEL GA002	Nk Biotechnical Engineering Co.	1993-05-12	278
K923964	NK GRASP SENSOR, MODEL GA001	Nk Biotechnical Engineering Co.	1993-05-12	278
K923963	NK DIGI-GRIP SENSOR, MODEL DGR001	Nk Biotechnical Engineering Co.	1993-03-31	236
K923262	DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER	John Chatillon & Sons, Inc.	1992-10-27	117
K922029	REMUSK MP	Equipement Biomedical Specialise, Inc.	1992-10-06	158
K922940	CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002	Exos, Inc.	1992-10-05	109
K921268	NK DYNA-GRIP SENSOR, MODEL DG001	Nk Biotechnical Engineering Co.	1992-07-14	120
K920183	TECH DYNE - HP-2000, SKREEN TEST, RMS-200	Tech Dyne Group	1992-06-15	152
K914436	CLINICAL HANDMASTER SYSTEM OR CHMS	Exos Medical Products	1992-01-02	90
K914057	NK PINCH SENSOR, MODEL PA001	Nk Biotechnical Engineering Co.	1991-12-09	90
K914055	PINCH SENSOR, MODEL PF001	Nk Biotechnical Engineering Co.	1991-12-09	90
K914054	NK GRASP SENSOR, MODEL GR001	Nk Biotechnical Engineering Co.	1991-12-09	90
K914059	NK DEVIATION SENSOR, MODEL DV001	Nk Biotechnical Engineering Co.	1991-12-09	90
K914056	NK PINCH SENSOR, MODEL PF002	Nk Biotechnical Engineering Co.	1991-12-09	90
K914058	NK PINCH SENSOR, MODEL PA002	Nk Biotechnical Engineering Co.	1991-12-06	87
K912526	GS-220 HAND IMPAIRMENT EVALUATION SYSTEM	J-Tech, Inc.	1991-09-05	90
K901290	ELECTRO-GONIOMETER DIAGNOSTIC DEVICE	Chattanooga Group, Inc.	1990-10-01	195
K893537	GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM	Greenleaf Medical Systems, Inc.	1989-10-10	155
K884165	MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS	Spark Instruments & Academics, Inc.	1988-10-26	22
K881388	KIN-COM JR	Chattanooga Group, Inc.	1988-04-21	17
K880464	DYNATRON II	Dynatronics Laser Corp.	1988-03-08	34
K860226	FORCE EVALUATION AND TESTING SYSTEM (FETS)	Hoggan Health Industries, Inc.	1986-03-27	64
K850697	DIGITAL GRIP/PINCH STRENGTH METOR	Chattanooga Group, Inc.	1985-05-14	82
K812899	MED-EX	Chattanooga Group, Inc.	1981-11-06	21
K811312	MYO-METRIC II	Mycron Medical, Inc.	1981-06-09	29

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