Atlas FDA

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

Corindus, Inc. — Predicate Candidate Screening

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

122 daysmedian FDA review time
282 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221464CorPath GRX SystemCorindus, Inc.2022-07-27690
K202275CorPath GRX SystemCorindus, Inc.2020-12-111220
K180517CorPath GRX SystemCorindus, Inc.2018-03-29300
K173806CorPath GRX SystemCorindus, Inc.2018-03-01760
K173288CorPath GRX SystemCorindus, Inc.2018-02-151220
K160121CorPath GRX SystemCorindus, Inc.2016-10-272820
K152999CorPath 200 SystemCorindus, Inc.2016-03-181570
K150892CorPath 200 SystemCorindus, Inc.2015-10-021830
K120834CORPATH 200 SYSTEMCorindus, Inc.2012-07-191220

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