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

KNN · Predicate Candidate Screening

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

27 daysmedian FDA review time

178 days90th percentile

64clearances measured

K-number	Device	Applicant	Decided	Review days
K211919	KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat	Kinetic Innovative Seating System, LLC	2022-03-04	256
K942309	DYNASTY U1-31 (GELL/CELL)	Foley & Lardner	1994-11-07	178
K942310	DYNASTY GC 12550 (GELL/CELL)	Foley & Lardner	1994-11-07	178
K942308	DYNASTY GC 12400 (GELL/CELL)	Foley & Lardner	1994-11-07	178
K942311	DYNASTY U1-33 AGM	Foley & Lardner	1994-11-07	178
K942260	ALDEN WHEELCHAIR CUSHION	Ward and Assoc.	1994-05-26	17
K942312	ALDEN LINEAGE WHEELCHAIR CUSHION	Lewis W. Ward	1994-05-26	13
K933051	ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION	General Components Intl., Inc.	1993-10-12	140
K923942	RHOMBO MEDICAL RHOMBO-FILL	International Medical Products, Inc.	1993-03-24	231
K925980	PM	Pathfinder Intl. Corp.	1993-03-24	119
K923364	TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST	Labac Systems, Inc.	1993-03-22	257
K925336	VALU-PLUS PAD	Valmed, Inc.	1993-02-12	113
K923366	TILT SEATING SYSTEM	Labac Systems, Inc.	1993-02-12	219
K923186	NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC	Roho, Inc.	1992-09-09	71
K921369	BIOMEDICAL HORIZONS MODEL 1001	Biomedical Horizons, Inc.	1992-05-11	52
K921027	MANUAL CHAIR BASE	Labac Systems, Inc.	1992-03-20	17
K915629	CUSHION, WHELCHAR AND FLOTATION	Invacare Corp.	1992-01-09	23
K915368	SERENA WHEELCHAIR CUSHIONS	A & C Medical Supply	1991-12-20	23
K913548	PIN DOT ALUMINUM PAN	Pin Dot Products, Inc.	1991-09-05	27
K913511	IMPALA AXLES	Pin Dot Products, Inc.	1991-09-05	29
K913507	ARMREST	Pin Dot Products, Inc.	1991-09-05	29
K913553	PIN DOT GROWTH/DIAL LINKS	Pin Dot Products, Inc.	1991-09-05	27
K913550	PIN DOT TRUNION MOUNTS	Pin Dot Products, Inc.	1991-09-05	27
K913549	PIN DOT MOUNTING BRACKETS	Pin Dot Products, Inc.	1991-09-05	27
K913545	PIN DOT FLIP-DOWN ABDUCTOR	Pin Dot Products, Inc.	1991-09-05	27
K913546	IMPALA CASTERS	Pin Dot Products, Inc.	1991-09-05	27
K913509	IMPALA WHEELS	Pin Dot Products, Inc.	1991-09-05	29
K913552	PIN DOT FOOTREST PRODUCTS	Pin Dot Products, Inc.	1991-08-29	20
K905013	T.C.S. TOTAL CONTACT SEAT	Fundamental Products Co.	1990-12-19	43
K904913	HANDI-TRAK WHEELCHAIR SNOW CHAINS	Handi-Trak, Inc.	1990-11-07	7
K900839	THE CAROLINA ROCKER	Artec Environmental Monitoring Division	1990-04-18	55
K890178	WHEELCHAIR STUMP SUPPORT	Gerber Chair Mates, Inc.	1989-09-11	237
K894770	PERSONAL BACK WITH FIP KIT	Canadian Posture and Seating Centre, Inc.	1989-09-11	47
K894960	E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE	E.Z. Lock, Inc.	1989-09-05	29
K885105	SLIDING ARM SUPPORT	Rolcontrol Products, Co., Inc.	1988-12-27	15
K885104	LAYDOWN ARM SUPPORT MECHANISM	Rolcontrol Products, Co., Inc.	1988-12-27	15
K885106	REMOVABLE BATTERY POWER SYSTEM	Rolcontrol Products, Co., Inc.	1988-12-27	15
K884052	GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT	Professional Service Unltd.	1988-10-26	30
K883679	WHEELS-OFF QUICK RELEASE AXLE SYSTEM	Rolcontrol Products, Co., Inc.	1988-09-13	26
K882253	STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT	Stoute'S "Assist-Seat" Corp.	1988-06-27	27
K882012	LIFESTYLE SOF. CARE GEL CHAIR CUSHION	Gaymar Industries, Inc.	1988-05-23	10
K870698	VAN-TEC PROSTATE BIOPSY NEEDLE	Van-Tec, Inc.	1987-03-25	34
K870299	REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS	Redman, Inc.	1987-02-10	13
K863385	(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE	Cook Urological, Inc.	1986-11-04	62
K862887	UPHOLSTERED BUCKET SEAT	Mednet, Inc.	1986-08-14	23
K861755	SHS CUSHION/WHEELCHAIR	Special Health Systems, Ltd.	1986-05-23	17
K861751	THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS	Special Health Systems, Ltd.	1986-05-23	17
K861754	KINESETHETIC SEATING SYSTEM/WHEELCHAIR	Special Health Systems, Ltd.	1986-05-23	17
K854710	BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID	Reloke Co.	1986-04-16	146
K855181	COMFORTEX WHEELCHAIR CUSHION	Comfortex, Inc.	1986-01-13	18

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