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

KXH — Predicate Candidate Screening

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

101 daysmedian FDA review time

393 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K122174	PEDIATRIC POSITIONER PAD SET	Ge Healthcare Coils (Usa Instruments, Inc.)	2012-11-16	116
K953246	OCTOROLL	Octostop, Inc.	1995-09-29	80
K930124	VARIANT OF OCTOSTOP AND OCTOPAQUE	Octostop, Inc.	1994-02-09	393
K933134	SPECTRUM DG-P7000 PEDIATRIC CRADLE	Spectrum X-Ray Corp.	1993-10-07	101
K930357	ACCESSORY TO UNIVERSAL OCTOPAQUE	Octostop, Inc.	1993-07-13	168
K884292	STRETCHER TABLE	Fischer Imaging Corp.	1989-03-31	170
K863890	MAMM-AIRE	Ar Custom Medical Products, Ltd.	1986-10-14	8
K840463	DIGITAL CRADLE	Spectrum X-Ray Corp.	1984-02-21	19
K813561	SPECTRUM PEDIATRIC CARDLE TABLE	Spectrum X-Ray Corp.	1982-01-29	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