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

FRP · Predicate Candidate Screening

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

92 daysmedian FDA review time

238 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K082367	INFANT SLEEP BEANIE	Life Innovations, LLC	2009-06-12	298
K090284	RES-Q INFANT WEDGE AND SLING	Cr Enterprises, LLC	2009-06-05	120
K062143	KOZY COMFORT INFANT POSITIONER	Alfred E Mann Inst. For Biomedical Engineering	2006-10-24	89
K060986	HEAD BED	Steven H. Warnock, M.D.	2006-07-11	92
K051300	ROBIN HOOD VEST	Kamber Corporation	2005-12-08	204
K041996	NIGHTFORM	Plastic Surgery Solutions, LLC	2004-08-03	8
K003511	KENDALL-LTP TURNER SAVE-A-LINE	The Ludlow Company LP	2001-01-24	71
K943017	NEONATAL RESTRAINT AND COMFORT SYSTEMS	K.Bowmed, Inc.	1995-01-19	209
K932636	THE TUCKER SLING	Tucker Designs, Ltd.	1994-01-26	238
K905630	INFANT REFLUX SLING	Pedicraft, Inc.	1991-03-13	89
K905629	PEDICRAFT INFANT REFLUX WEDGE	Pedicraft, Inc.	1991-03-13	89
K882544	CUDDLE UP PILLOW	Ohio Medical Instrument Co., Inc.	1989-01-31	224
K844176	PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS	Premie Comfort Products	1985-01-23	90
K810609	PEDIATRIC POSITION HOLDER	Kaye Products, Inc.	1981-03-20	14

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