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

IKK — Predicate Candidate Screening

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

45 daysmedian FDA review time

209 days90th percentile

61clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K123746	AMES THERAPY DEVICE	Ames Technology, Inc.	2013-05-24	169	0
K952090	HUMAC SYSTEM	Computer Sports Medicine, Inc.	1995-12-11	222	0
K951770	BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP	Biodex Medical Systems, Inc.	1995-11-16	213	0
K951916	CC RIDER, MODEL ME180	Mettler Electronics Corp.	1995-10-04	163	0
K950095	CYBEX 770	Cybex	1995-06-21	162	0
K942229	MOTIVATOR FTR 2000	Hogan & Hartson	1995-02-27	297	0
K944732	DEXTER ISOKINETIC	Cedaron Medical, Inc.	1995-02-03	162	0
K924414	THE BTE DYNAMIC LIFT	Baltimore Therapeutic Equipment Co.	1993-02-12	165	0
K923350	CLOSED CHAIN ATTACHMENT, MODEL #820-520	Biodan Medical Systems, Ltd.	1992-07-23	15	0
K922772	TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR	Biodan Medical Systems, Ltd.	1992-07-13	34	0
K922092	SINGLE CHAIR INTEGRAL BACK ATTACHMENT	Biodan Medical Systems, Ltd.	1992-05-26	21	0
K915144	DEXTER HAND EVALUATION AND THERAPY SYSTEM	Cedars Medical Center	1992-04-02	140	0
K915846	BIODEX SYSTEM 2 AUTOPROGRAM	Biodex Corp.	1992-01-13	31	0
K915648	BIODEX SYSTEM 2 AUTOPROGRAM	Biodex Corp.	1992-01-09	27	0
K913021	BIODEX,MODEL B-2000	Biodex Corp.	1991-10-03	86	0
K913020	BIODEX SYSTEM 2,MODEL S2-S	Biodex Corp.	1991-10-03	86	0
K911805	KIN-COM ASYMMETRICAL BACK SYSTEM	Chattanooga Group, Inc.	1991-07-03	71	0
K911666	MEDX MACHINE	Medx Corp.	1991-07-03	82	0
K905525	CYBEX 6000	Cybex	1991-02-14	66	0
K904898	TORQUE FRAME QTF1000	Medmetric Corp.	1990-11-28	29	0
K901566	PROMATRON 3000	Promatek Medical Systems, Inc.	1990-10-29	209	0
K903429	LIDO LINEA	Loredan Biomedical, Inc.	1990-08-14	14	0
K902219	KRONAMAX HUMAN PERFORMANCE LAB	Physicians Digital Co.	1990-07-25	70	0
K900450	BIODEX LIFT SIMULATOR	Biodex Corp.	1990-07-24	175	0
K881681	CYBEX BACK TESTING AND REHABILITATION SYSTEM	Cybex	1990-04-25	736	0
K881676	LINEAR LIFT DEVICE	Cybex	1990-04-25	736	0
K900741	BIODEX BACK SYSTEM ATTACHMENT	Biodex Corp.	1990-02-26	10	0
K896553	MEDX CERVICAL EXTENSION TEST & REHAB MACHINE	Medx Corp.	1990-01-02	46	1
K894662	TEST ONE	Primed Products, Inc.	1989-12-13	142	0
K895398	BIO-COORDINATOR SYSTEM	Bio-Harmonizer, Inc.	1989-09-28	21	0
K895236	MEDX REHABILITATION MACHINE	Medx Corp.	1989-09-14	42	0
K884487	LIDO TM ACTIVE BACK	Loredan Biomedical, Inc.	1988-11-18	24	0
K873659	MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO	Universal Gym Equipment, Inc.	1988-04-21	224	0
K880230	SIXALYZER	Lukens Corp.	1988-03-16	56	0
K880017	LIDO(TM) LIFT	Loredan Biomedical, Inc.	1988-02-26	52	0
K880018	LIDO(TM) WORKSET	Loredan Biomedical, Inc.	1988-02-26	52	0
K875235	ISOKINETIC SYSTEM, TESTING AND EVALUATION	Orthopedic Systems, Inc.	1988-01-19	28	0
K872911	CYBEX 340	Cybex	1987-09-24	62	0
K871557	DISCIPLINE II RTD	Physio Systems, Inc.	1987-08-26	126	0
K872199	DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER	Dyno-Max Co.	1987-08-21	74	0
K871793	LIDO ACTIVE	Loredan Biomedical, Inc.	1987-06-05	29	0
K863313	GRIP STRENGTH DEVICE (GSD)	Devcom, Inc.	1986-09-09	14	0
K862998	PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT	Kent Design & Manufacturing, Inc.	1986-08-20	12	0
K862995	PORTABLE ISOKINETICS 3003 SHOULDER UNIT	Kent Design & Manufacturing, Inc.	1986-08-20	12	0
K862994	PORTABLE ISOKINETICS 3002 ISO KANE II	Kent Design & Manufacturing, Inc.	1986-08-20	12	0
K862996	PORTABLE ISOKINETICS 3004 KNEE UNIT	Kent Design & Manufacturing, Inc.	1986-08-20	12	0
K862997	PORTABLE ISOKINETICS 3005 HIP UNIT	Kent Design & Manufacturing, Inc.	1986-08-20	12	0
K862993	PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT	Kent Design & Manufacturing, Inc.	1986-08-20	12	0
K862780	TRU-KINETICS (TM)	Tru-Trac	1986-08-04	28	0
K862096	STATIC STRENGTH TESTER	Lowcountry Orthopaedic Assoc., P.A.	1986-07-15	43	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