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

FMW — Predicate Candidate Screening

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

148 daysmedian FDA review time

267 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K152884	DermaTherapy Bed Linens	Precision Fabrics Group, Inc.	2016-06-20	264
K061242	DERMATHERAPY, MODEL 22216	Precision Fabrics Group, Inc.	2007-01-25	267
K001003	Z-NET	Demite Limited	2001-12-10	621
K992702	EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVE	Allergy Direct	1999-11-08	88
K940327	INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING S	W. L. Gore & Associates, Inc.	1994-02-25	32
K935220	CORE PREVENT MATTRESS MODIFICATION	Paladin Medical, Inc.	1993-11-29	48
K924807	REUSABLE INCONTIENT UNDERPAD	Perfect Fit Industries, Inc.	1993-02-10	160
K924477	WIPEABLE PILLOW	Perfect Fit Industries, Inc.	1993-01-29	148
K923173	OBALON COVER	Turnsoft, Inc.	1992-11-06	129
K921928	SOFT-COVER	Adroit Medical Systems, Inc.	1992-11-06	196
K903382	ALLERGY CONTROL COVERS	Allergy Control Products, Inc.	1990-11-02	98
K902446	DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST	Mallinckrodt Group, Inc.	1990-08-10	70
K832483	MATTRESS COVER, ANTI-MICROBIAL	American Threshold Industries, Inc.	1984-02-04	194
K780033	MATTRESSES, CONDUCTIVE & COVERS	Chase Mfg. Co.	1978-02-21	43

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