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

KEW — Predicate Candidate Screening

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

38 daysmedian FDA review time

88 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K891604	THE CEN-SLIDE(TM) CENTRIFUGE TUBE	Davstar California, Inc.	1989-06-16	88
K890042	MICROSCOPE SLIDES PRECOATED	Stat Path	1989-01-13	8
K882357	MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY	Stat Path	1988-06-16	9
K831065	SECTIONING AID KIT	Technicon Instruments Corp.	1983-06-08	65
K820100	FROSTED GLASS SLIDES	Stan-Pak Ent.	1982-03-04	50
K813242	QUANTIMETRIC 2 TEST KIT	Kallestad Laboratories, Inc.	1981-12-02	15
K800232	ABCO ULTRA SLIDE MICROSCOPE SLIDE	Abco Dealers, Inc.	1980-02-21	16
K760278	SLIDE, LAB-TEK COVERED MICRO	Miles Laboratories, Inc.	1976-08-30	38

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