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

ION — Predicate Candidate Screening

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

22 daysmedian FDA review time

71 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days
K120783	ABLE-X	Im-Able, Ltd.	2012-06-20	97
K885343	STANDEX	Alt, Inc.	1989-05-01	124
K851065	GRAVITY KING (DEEMED SE 87/09/18)	Unique Functional Products	1985-06-13	90
K840551	MOBILIZER	Lossing Orthopedic, Inc.	1984-03-23	44
K833870	KNEE WALKER	Maddak, Inc.	1983-11-29	21
K833249	FITNESS	Fitness Equipment Co., Inc.	1983-11-07	45
K832968	PEDAL EXERCISER	Maddak, Inc.	1983-09-29	28
K831543	ADJUST. WEIGHTS-BK5171-05,10,20 BEOK	Fred Sammons, Inc.	1983-06-24	43
K831538	DELUXE ADJUST-ANGLE BOARD-BK4066	Fred Sammons, Inc.	1983-06-08	27
K831033	GIREX	Lancer Assoc.	1983-04-27	27
K830400	MADDATRAINER HAND EXERCISER	Maddak, Inc.	1983-03-09	30
K830560	EXERCISER, PASSIVE, NON MEASURING	Kaye Products, Inc.	1983-03-09	14
K823236	BACK ON TRACK INVERSION THERAPY & EXER	Lossing Orthopedic, Inc.	1983-01-21	81
K823623	INFLATABLE HEAVY PLASTIC EXERCISER	Fred Sammons, Inc.	1982-12-28	22
K823618	PROGRESSIVE RESISTANCE EXERCISE CUFF	Fred Sammons, Inc.	1982-12-22	16
K823619	PLASTIC ELASTOMER ENCASED IN TERRY CLOTH	Fred Sammons, Inc.	1982-12-22	16
K823620	PLASTIC ELASTOMER IN CUBE FORM EXERCISE	Fred Sammons, Inc.	1982-12-22	16
K822906	PHYSICAL MEDICINE & REHABILITATION EQUIP	I-Rep, Inc.	1982-10-15	16
K821857	BK-5305 MULTIPLE HAND GRID	Fred Sammons, Inc.	1982-07-02	9
K821855	VISCO HANDEX-VARIOUS MODELS	Fred Sammons, Inc.	1982-07-02	9
K813633	MODELING COMPOUND AND FOAM EXERCISER	Fred Sammons, Inc.	1982-01-19	21
K813099	BACK RIE	Back Rite	1981-11-24	21
K812474	BABY WALKER W/TOY CHEST	Maddak, Inc.	1981-09-14	14
K812351	NON-MEASURING EXERCISERS	Fred Sammons, Inc.	1981-09-14	27
K810444	NON-MEASURING EXERCISERS	Fred Sammons, Inc.	1981-03-04	13
K801710	BK-5315-01 FOAM HAND EXERCISER, SMALL	Fred Sammons, Inc.	1980-08-07	14
K801453	FINGER, HAND & WRIST EXERCISER	Robert W. Slack	1980-08-04	41
K792642	THE VARIABLE LOAD KENETIC ENERGIZER	W.F. Pogue	1980-01-28	33
K800017	COLOR CODED PUTTY SOFT, REGULAR & FIRM	Fred Sammons, Inc.	1980-01-21	19
K790572	LOUNGE, TILT-A-BODY STRETCH	Innovative Products, Inc.	1979-04-10	18
K790530	PUSH BALL INCLINE	Maddak, Inc.	1979-04-03	19
K790191	VISA-GRIP	Premier Sundries, Inc.	1979-02-08	13
K781350	OBJECTS PRECISION HANDLING TEST KIT	Metro. Hospital & Health Center	1978-10-17	71
K772404	FINGER EXERCISE BOARD	Fred Sammons, Inc.	1978-02-13	48
K770658	EXERCISER, LEG, LOWER EXTREMITY	Robert R. Moore	1977-06-17	71
K770436	EXERCISER, EXTENSOR WAND	Maddak, Inc.	1977-04-06	30
K770144	RHEUMATOID HAND GYM	Maddak, Inc.	1977-01-28	4
K761313	4-BAR KNEE-SHIN SET-UP	Hosmer Dorrance Corp.	1977-01-10	28
K761314	FLEXION-BRAKING KNEE-SHIN ASSEMBLY	Hosmer Dorrance Corp.	1977-01-10	18
K761135	SHORT INFLATED ROLLS	Fred Sammons, Inc.	1976-12-02	13
K761120	SPIN-A-PULL	Fred Sammons, Inc.	1976-12-02	13
K760305	BALLOONS, BK-8112, 8114	Fred Sammons, Inc.	1976-09-08	47
K760304	CANOPY, PARACHUTE, BK-8110	Fred Sammons, Inc.	1976-09-08	47

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