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

Heidelberg Engineering — Predicate Candidate Screening

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

86 daysmedian FDA review time

151 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K101223	SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT,	Heidelberg Engineering	2010-10-01	151
K063191	HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH,	Heidelberg Engineering	2006-10-31	11
K052935	HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)	Heidelberg Engineering	2006-01-13	86
K042742	HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT	Heidelberg Engineering	2004-10-13	9
K971671	HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)	Heidelberg Engineering	1997-07-29	83
K944261	RETINA ANGIOGRAPH	Heidelberg Engineering	1994-11-14	74
K943955	RETINA FLOWMETER	Heidelberg Engineering	1994-11-14	91
K943956	RETINA TOMOGRAPH AND FLOWMETER	Heidelberg Engineering	1994-11-14	91
K912891	HEIDELBERG RETINA TOMOGRAPH	Heidelberg Engineering	1991-09-27	88

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