Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

IKX — Predicate Candidate Screening

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

21 daysmedian FDA review time

46 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K862895	TRICYCLES	Mednet, Inc.	1986-08-13	22
K842650	WALL GRAB BARS 98130-98136	Guardian Products Co., Inc.	1984-08-10	31
K831541	TUB TRANSFER BENCH BK6481	Fred Sammons, Inc.	1983-06-02	21
K823640	BATH TUB SAFETY BAR	Fred Sammons, Inc.	1983-01-21	46
K823639	BOARD TO TRANSFER PARALYZED PATIENT FROM	Fred Sammons, Inc.	1983-01-21	46
K823634	CHAIR OR BED LEG EXTENDERS	Fred Sammons, Inc.	1982-12-28	22
K823153	BATH TUB SEAT & BATH BOARD	Orthion Corp.	1982-11-05	16
K823154	SHOWER STOOL W/HANDLES	Orthion Corp.	1982-11-05	16
K821903	DISC-O-AID	M. Dahm International Aps	1982-07-20	22
K821010	BATHTUB TRANSFER BENCH	Guardian Products Co., Inc.	1982-04-21	9
K813629	BK-6111 HI-D TRANSFER BOARD	Fred Sammons, Inc.	1982-01-19	21
K812475	TRANSFER BENCH	Maddak, Inc.	1981-09-14	14
K810449	TRANSFER AIDS	Fred Sammons, Inc.	1981-03-04	13
K810275	GRAB BARS	Maddak, Inc.	1981-02-12	10
K792247	TAYLOR PATIENT TRANSFER BOARD	Taylor Medical Equipment	1979-11-30	23
K781201	BOARD, TRANSFER, FENDER	Fred Sammons, Inc.	1978-07-31	17
K780935	GRAB BAR	Orthopedic Equipment Co., Inc.	1978-06-19	12
K772417	SLIDING BOARD	Fred Sammons, Inc.	1978-01-05	9

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