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

IOL — Predicate Candidate Screening

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

41 daysmedian FDA review time

127 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K950376	PARKER MODEL PM	Parker Treadmill Co., Inc.	1995-09-06	218	0
K950377	PARKER MODEL PE	Parker Treadmill Co., Inc.	1995-09-06	218	0
K925839	TRACKMASTER	Jas Manufacturing Co., Inc.	1993-06-24	218	0
K930261	RTM REHABILITATION TREADMILL, MODEL #945-200	Biodan Medical Systems, Ltd.	1993-05-26	127	0
K904556	MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB	Boston Scientific Corp	1991-12-18	439	0
K913518	TA620 TREADMILL CONTROLLER	Siemens Burdick, Inc.	1991-10-24	78	0
K910867	T600 TREADMILL	Siemens Burdick, Inc.	1991-05-31	91	0
K911751	MEDTRACK TREADMILL	Quinton, Inc.	1991-05-29	41	0
K897179	ORBITER(TM) TREADMILL	Lee-Meredith Industries, Inc.	1990-02-15	49	0
K895104	AQUATREX UNDERWATER TREADMILL SYSTEM	Edmonds Medical Systems	1989-12-04	111	0
K893032	PACER R 9 TREADMILL	Pacer Industries, Inc.	1989-07-27	94	0
K890793	STARTRAC	Unisen, Inc.	1989-03-16	27	0
K885062	MODIFIED Q-SERIES OF TREADMILLS	Quinton, Inc.	1988-12-27	21	0
K864013	MODEL Q55XT POWERED TREADMILL	Quinton, Inc.	1986-11-14	30	1
K863299	MODIFIED Q50 MEDICAL TREADMILL	Quinton, Inc.	1986-09-09	15	0
K862741	Q50 MEDICAL TREADMILL	Quinton, Inc.	1986-07-29	8	0
K861347	R1596 POWERED EXERCISE EQUIPMENT	Tri W-G, Inc.	1986-05-02	25	0
K854147	BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL	Battle Creek Equipment Co.	1985-12-27	77	0
K854148	BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL	Battle Creek Equipment Co.	1985-12-17	67	0
K854283	CAMBRIDGE MODEL XT1000	Cambridge Medical Instruments, Inc.	1985-11-13	20	0
K851631	TMX-C1/C2 TRADMILL CONTROLLER ACCESS.	Eaton Medical Group	1985-07-15	88	0
K851629	TMX-70 TREADMILL	Eaton Medical Group	1985-07-09	82	0
K851630	TMX-80 TREADMILL	Eaton Medical Group	1985-07-09	82	0
K850044	TREADMILL E-17	Del Mar Avionics	1985-04-04	87	0
K843859	LAUF-ERGOTEST JUNIOR	Erich Jaeger, Inc.	1984-11-27	57	0
K843853	LAUF-ERGOTEST	Erich Jaeger, Inc.	1984-11-27	57	0
K840280	ROAD RUNNER ELECTRIC TREADMILL	Battle Creek Equipment Co.	1984-02-04	12	0
K833588	VASCULAR LABORATORY TREADMILL VT1	Medasonics, Inc.	1983-11-14	33	0
K830146	PROGRAM. TREADMILL CONTROLLER #645	Quinton, Inc.	1983-02-02	16	0
K823003	Q65 MEDICAL TREADMILL	Quinton, Inc.	1982-10-27	15	0
K820548	POWERED TREADMILL	Ogden Health Products	1982-03-15	13	0
K820478	QUINTON Q55 MEDICAL TREADMILL	Quinton, Inc.	1982-03-11	17	0
K813485	SAS EDUCATIONAL CHART	Structural Analysis Systems, Inc.	1982-01-29	59	0
K813486	TELETRED GAIT ANALYSIS SYSTEM	Structural Analysis Systems, Inc.	1982-01-29	59	0
K802836	SERIES 1800 EXERCISE TREADMILL	Marquette Electronics, Inc.	1980-12-11	29	0
K792661	TREADMILL MODEL 3060	Cambridge Instruments, Inc.	1980-02-19	55	0
K792590	AP-1 AUTO PROGRAMMER	Burdick Corp.	1980-01-04	18	0
K771697	CARDIO-EXERCISE TREADMILL 550	Quinton, Inc.	1977-09-20	14	0
K770240	TREADMILL STRESS EXERCISE SYSTEM	Burdick Corp.	1977-02-14	7	0
K761041	POWERED TREADMILL (30/ST)	Physio-Control Corp.	1976-12-09	24	0
K761040	POWERED TREADMILL (20/ST)	Physio-Control Corp.	1976-12-09	24	0
K760509	TREADMILL, DIAGNOSTIC	Medcraft Corp.	1976-08-30	6	0
K760275	TREADMILL (TMS-300)	Burdick Corp.	1976-08-11	20	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