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

Leica Biosystems Imaging, Inc. — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

263 daysmedian FDA review time

266 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253554	Aperio GT 450 DX; Aperio GT 180 DX	Leica Biosystems Imaging, Inc.	2026-08-07	266	0
K253561	Aperio iQC DX Software	Leica Biosystems Imaging, Inc.	2026-08-07	263	0
K232202	Aperio GT 450 DX	Leica Biosystems Imaging, Inc.	2024-04-16	266	0
K190332	Aperio AT2 DX System	Leica Biosystems Imaging, Inc.	2019-05-20	95	0
K141109	APERIO EPATHOLOGY EIHC IVD SYSTEM	Leica Biosystems Imaging, Inc.	2014-07-29	91	1

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