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

KIC — Predicate Candidate Screening

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

27 daysmedian FDA review time

98 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K960189	GEL-T CUSHION	Span-America Medical Systems, Inc.	1996-02-07	22
K953352	PROTEAM CUSHION	Iskra.Med	1995-11-29	135
K954117	CUSTOMCARE SEATING SYSTEM	Span-America Medical Systems, Inc.	1995-10-13	42
K950085	MULTICURE(R) S GEL PAD	Multigestion (Deutschland) GmbH	1995-07-13	184
K945667	MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION	Micos Medical Systems	1995-02-21	96
K941858	GEL CUSHION	Hollister, Inc.	1994-05-05	20
K911843	ZERO-G(TM) GEL/FOAM MATTRESS TOPPER	Steridyne Corp.	1991-05-30	35
K872739	SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION	D.A. Schulman, Inc.	1987-07-30	21
K864109	C' AIRECUSH SEAT CUSHION	Medical Industries America, Inc.	1986-11-14	24
K864108	PUSH CUSH	Medical Industries America, Inc.	1986-11-14	24
K861327	ROHO HEEL PAD	Roho, Inc.	1986-06-02	54
K855072	MAXIMUS CUSHION	Jay Medical, Ltd.	1986-03-10	81
K851814	WHEELCHAIR CUSHIONS	Dignicare	1985-07-09	74
K851027	SOF. CARE CUSHION & SOF-CARE CUSHION COVER	Gaymar Industries, Inc.	1985-06-18	98
K842380	PRESSURE RELIEF SEAT CUSHION	American Pharmaseal Div. Ahsc	1984-06-28	10
K842120	ZERO-G	Steridyne Corp.	1984-06-08	10
K834517	JAY CUSHION	Jay Medical, Ltd.	1984-01-17	27
K831247	SAFE-SEAT WHEELCHAIR CUSHION	D.A. Schulman, Inc.	1983-05-16	28
K830426	INFLATABLE INVALID RING	Maddak, Inc.	1983-04-28	78
K830427	ARM CUSHION	Maddak, Inc.	1983-03-29	48
K823903	RUBBER INFLATABLE RING	Duro-Med Ind., Inc.	1983-01-14	17
K820236	WATER FLOATATION PAD	Gottfried Medical, Inc.	1982-02-04	7
K813225	GEL FLOTATION CUSHION	Jefferson Industries, Inc.	1981-12-03	23
K810649	INVALID CUSHION	First Industries, Inc.	1981-03-26	16
K810440	SILICONE ELBOW, BED AND CHAIR PADS	Fred Sammons, Inc.	1981-03-12	21
K803137	CONPHAR INVALID RING	Conphar, Inc.	1981-01-08	27
K801217	SKIL-CARE GEL WEDGE, FLOTATION PAD	Skil-Care Corp.	1980-05-30	9
K780941	CONDUCTIVE CUSHION	Markham Service Co., Inc.	1978-07-27	50
K760613	FLOTATION UNIT, CHAIR	Medpro, Inc.	1976-10-14	34

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