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

Maddak, Inc. — Predicate Candidate Screening

51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

16 daysmedian FDA review time

75 days90th percentile

51clearances measured

K-number	Device	Applicant	Decided	Review days
K841700	WALK & ROLL	Maddak, Inc.	1984-05-11	18
K841698	HEAT PACK	Maddak, Inc.	1984-05-10	17
K841695	CRAWLER	Maddak, Inc.	1984-05-10	17
K841691	SPLIT SEAT POSITIONING CHAIR	Maddak, Inc.	1984-05-09	16
K841692	PRONE STANDER	Maddak, Inc.	1984-05-09	16
K841693	STANDING FRAME	Maddak, Inc.	1984-05-09	16
K841697	HYDRO-THERO PAD	Maddak, Inc.	1984-05-09	16
K834311	NIGHT TRAINER	Maddak, Inc.	1984-03-30	126
K833870	KNEE WALKER	Maddak, Inc.	1983-11-29	21
K833177	GLOSSECTOMY FEEDING SPOONS	Maddak, Inc.	1983-10-31	42
K833090	SENSORY ROLLER MASSAGER	Maddak, Inc.	1983-10-14	32
K832968	PEDAL EXERCISER	Maddak, Inc.	1983-09-29	28
K832970	CANE REACHER	Maddak, Inc.	1983-09-29	28
K832969	WALKING CANE	Maddak, Inc.	1983-09-29	28
K830425	TOILET SEAT RAISED	Maddak, Inc.	1983-05-09	89
K830426	INFLATABLE INVALID RING	Maddak, Inc.	1983-04-28	78
K830427	ARM CUSHION	Maddak, Inc.	1983-03-29	48
K830400	MADDATRAINER HAND EXERCISER	Maddak, Inc.	1983-03-09	30
K812479	POSTURE MIRROR	Maddak, Inc.	1981-12-09	100
K812473	HEAD PROTECTOR	Maddak, Inc.	1981-12-02	93
K812654	VELCRO FINGER/TOE SPLINT	Maddak, Inc.	1981-09-25	8
K812655	VELCRO SPLINT STRAP FASTENERS	Maddak, Inc.	1981-09-25	8
K812482	FOAM WEDGE	Maddak, Inc.	1981-09-24	24
K812475	TRANSFER BENCH	Maddak, Inc.	1981-09-14	14
K812477	ARM SLING, POUCH TYPE	Maddak, Inc.	1981-09-14	14
K812474	BABY WALKER W/TOY CHEST	Maddak, Inc.	1981-09-14	14
K812478	MADDACOMFORT SLING	Maddak, Inc.	1981-09-14	14
K812480	LIMB HOLDER ARM SLING	Maddak, Inc.	1981-09-14	14
K812481	BACKREST	Maddak, Inc.	1981-09-14	14
K812483	SECURA BATH SEAT	Maddak, Inc.	1981-09-14	14
K810275	GRAB BARS	Maddak, Inc.	1981-02-12	10
K790559	ALARM	Maddak, Inc.	1979-06-01	74
K790532	FEVER TESTER	Maddak, Inc.	1979-05-29	75
K790531	ANUS STIMULATOR	Maddak, Inc.	1979-04-26	42
K790560	ROLLCHAIR, ORTHO BUCKET SEAT	Maddak, Inc.	1979-04-10	22
K790558	CERSA-CANE	Maddak, Inc.	1979-04-03	15
K790530	PUSH BALL INCLINE	Maddak, Inc.	1979-04-03	19
K790528	THERAPY GYROSCOPE	Maddak, Inc.	1979-04-03	19
K790529	WALKING AID	Maddak, Inc.	1979-04-03	19
K790561	OFFSET ALUMINUM CANE	Maddak, Inc.	1979-04-03	15
K790557	CRUTCH	Maddak, Inc.	1979-04-03	15
K790587	CANVAS WEDGE	Maddak, Inc.	1979-04-03	7
K790527	BURNETT-KETCHUM DYNAMIC HAND EXERCISER	Maddak, Inc.	1979-03-22	7
K770436	EXERCISER, EXTENSOR WAND	Maddak, Inc.	1977-04-06	30
K770147	AVON TILTING PUSH CHAIR 14	Maddak, Inc.	1977-02-02	9
K770148	CALIBRATED GRASPING TUBES	Maddak, Inc.	1977-02-01	8
K770165	MICRO-MIX PIPETTE SHAKER	Maddak, Inc.	1977-01-31	6
K770145	YORKHILL CHAIR	Maddak, Inc.	1977-01-28	4
K770166	MANOY WALKING AID	Maddak, Inc.	1977-01-28	3
K770144	RHEUMATOID HAND GYM	Maddak, Inc.	1977-01-28	4

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