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

IWY — Predicate Candidate Screening

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

63 daysmedian FDA review time

154 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K925705	ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM	Denar Corp.	1992-12-28	46
K884493	HEAD HOLDING DEVICE/SLEEP APNEA	X-Ray Systems	1989-01-12	78
K884847	MTD HEDREST	Composites Horizons, Inc.	1989-01-09	49
K864527	DUOCEPH	Gary E. Hall, Dds	1987-01-07	51
K850197	KELLER CEPHALOMETRIC DEVICE	Gary D. Keller	1985-03-22	63
K844549	HEAD-SPINE STABILIZER HSS-1	Imaging Accessories, Inc.	1985-03-01	100
K843340	PORTA-STAT	Porta-Stat, Inc.	1984-11-27	92
K834559	DELUXE WALL-MOUNTED CEPHALOMETER	Knochen Dental Laboratory	1984-02-21	55
K802140	LEKSELL STEREOTACTIC SYSTEM	Downs Surgical , Ltd.	1981-02-05	154
K772313	X-RAY CO-ORDINATOR	Rinn Corp.	1978-01-30	49

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