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

IKZ — Predicate Candidate Screening

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

91 daysmedian FDA review time

287 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K972486	PRESSUREGUARD IV	Span-America Medical Systems, Inc.	1998-02-20	233
K972111	RUMORS DYNAMIC AIR THERAPY UNIT	Hill-Rom, Inc.	1998-02-02	242
K962788	CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM	Gaymar Industries, Inc.	1997-04-30	287
K954671	THE FREEDOM BED	Probed Medical Technologies, Inc.	1996-04-01	174
K950756	PULMONEX DYNAMIC AIR THERAPY UNIT	Hill-Rom, Inc.	1995-05-30	102
K950681	MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LO	Invacare Corp.	1995-05-16	91
K933964	THE CRADLE	The Primal Energy Research Foundation	1994-10-03	413
K923710	OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED	Progressive Medical Technology, Inc.	1993-03-22	238
K922473	TURN EZ BED DEVICE	Med-Ez, Inc.	1992-09-09	106
K905390	KUDO (POWERED ROTATION BED)	Kinetic Concepts, Inc.	1991-01-08	39
K905113	ROTO REST; TRAUMA AND INTENSIVE CARE BED	Ethos Medical Products , Ltd.	1990-11-26	13
K873047	KEANE MOBILITY BED	Surgi-Med, Inc.	1987-10-15	72
K842604	EMERSON MOTION BED 6-MS & 6-ME	J. H. Emerson Co.	1984-07-20	15
K834563	EGERTON TURNING & TILTING BED	Kinetic Concepts, Inc.	1984-01-30	33
K823095	KINETIC MOTION BED	Motion Manufacturers, Inc.	1982-12-03	44
K822402	ROTO REST KINETIC TREATMENT TABLE PEDIA	Kinetic Concepts, Inc.	1982-10-22	73
K810220	POWERED PATIENT SYSTEM	Tri W-G, Inc.	1981-02-04	8

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