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

ISD — Predicate Candidate Screening

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

74 daysmedian FDA review time

458 days90th percentile

61clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K202979	MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/D	Lode B.V.	2020-12-21	82	0
K183296	REAL Immersive System	Penumbra, Inc.	2019-03-18	111	0
K143512	ActiSpec Activity Monitor	Sleep Modus, Inc.	2015-08-26	258	0
K112121	ERGOSELECT/GE	Ergoline GmbH	2012-10-31	464	0
K080545	ACTITRAINER	Actigraph, LLC	2008-07-24	148	0
K053078	ERGOSELECT 100 K/P, ERGOSELECT 200 K/P	Ergoline GmbH	2006-04-27	176	0
K990866	QUINTON MEDTRACK CR PLUS TREADMILL	Quinton, Inc.	1999-04-29	44	1
K990813	REHCOR	Electromed Corp.	1999-04-12	32	0
K962855	ULE-2, MULE-2, HAND ACCESSORY KIT	Penny and Giles Biometrics , Ltd.	1996-12-11	142	0
K952163	DAVID BACK CLINIC SYSTEM	Kinetic Resources, Inc.	1996-08-12	462	0
K941033	PHYSIO HAB	Longo Industries	1995-02-27	360	0
K940065	SES100	Southwest Ergonomics	1994-12-06	334	0
K934238	MULE	Penny and Giles Biometrics , Ltd.	1994-10-26	422	0
K930735	LORDEX LUMBAR EXTENSION MACHINE	Lordex, Inc.	1994-09-29	595	0
K933611	THE BTE WS30	Baltimore Therapeutic Equipment Co.	1994-06-20	336	1
K926279	UPPER BODY EXERCISER	Henley Intl.	1994-05-05	507	0
K926278	STAIR CLIMBER	Henley Intl.	1994-05-05	507	0
K926287	EXERCISE BICYCLE	Henley Intl.	1994-03-22	463	0
K926314	HYDRA FITNESS MODEL 311 TOTAL POWER	Henley Intl.	1994-03-18	458	0
K930253	CARDIO2 CTCKE	Ergometrx, Inc.	1993-10-18	272	0
K926170	STEPMILL EXERCISE SYSTEM	Stairmaster Sports/Medical Products, Inc.	1993-03-31	128	0
K922606	MULTI JOINT WEIGHT SYSTEM MODEL #940-100	Biodan Medical Systems, Ltd.	1992-06-19	17	0
K922602	CABLE COLUMN WEIGHT SYSTEM MODEL #940-200	Biodan Medical Systems, Ltd.	1992-06-19	17	0
K922603	TOTAL WORK INTEGRATOR, MODEL #940-110	Biodan Medical Systems, Ltd.	1992-06-19	17	0
K912140	STAIRMASTER MODEL 6000 ERGOMETER	Tri-Tech, Inc.	1991-12-17	217	0
K912056	GRAVITRON UPPER BODY SYSTEM EXERCISER	Tri-Tech, Inc.	1991-10-24	168	0
K912058	GAUNTLET STAIR CLIMBER	Tri-Tech, Inc.	1991-10-24	168	0
K912057	4000 PT EXERCISE SYSTEM	Tri-Tech, Inc.	1991-10-24	168	0
K912227	MONARK ERGOMETERS	Quinton, Inc.	1991-08-07	83	0
K904823	FLEXERCYCLE	Medmetric Corp.	1991-01-30	97	0
K894154	METABOLIC SYSTEMS	Cybex	1989-10-24	132	0
K890401	GOLDEN MEAN MACHINE(TM) (CLASS 2)	Bennett Ergonomic Labs, Inc.	1989-04-21	87	0
K880032	MEDEX MACHINE	Medex, Inc.	1988-02-11	37	1
K880271	RESUBMITTED EXCALIBUR	Quinton, Inc.	1988-02-03	13	0
K871494	UPPERCYCLE STATIONARY EXERCISE MACHINES	Engineering Dynamics Corp.	1987-05-06	20	0
K870872	DISCIPLINE I	Physio Systems, Inc.	1987-03-23	20	0
K864581	APPLIDYN	Grandcor Medical Systems	1987-01-21	62	0
K863884	PULSESTAR EXERCISE BIKE	Battle Creek Equipment Co.	1986-10-23	17	0
K861348	R1361 & R1372 MEASURED EXERCISE EQUIPMENT	Tri W-G, Inc.	1986-05-02	25	0
K851967	TORQUE FEEDBACK METER	Th Charters, Inc.	1985-07-19	74	0
K851946	REMOTE SPEED CONTROL	Th Charters, Inc.	1985-07-19	77	0
K851097	LODE MODEL CORIVAL ERGOMETER	Lode Corp.	1985-06-18	91	0
K850869	MFE COUCH ERGOMETER	Ketronic, Inc.	1985-06-12	103	0
K843850	UNIVERSAL-ERGOTEST	Erich Jaeger, Inc.	1984-11-27	57	0
K834360	3-D PASSIVE MOBILIZER	3-D Orthopedic, Inc.	1984-01-13	31	0
K834098	STATIONARY EXERCISE BICYCLE	Engineering Dynamics Corp.	1983-12-27	29	0
K832940	ROTAGYM	I-Rep, Inc.	1983-11-07	70	0
K801868	CAL-COUNT	Bayshore Systems Corp.	1980-08-27	22	0
K800939	COMPUTRIM 900	Amf, Inc.	1980-05-28	36	0
K800892	NUCLEAR STRESS TABLE (NST-1)	Technicare Corp.	1980-05-14	26	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