Atlas FDA

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

AbbVie , Inc. — Predicate Candidate Screening

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

261 daysmedian FDA review time
262 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142792AbbVie NJAbbVie , Inc.2015-01-141100
K142816AbbVie JAbbVie , Inc.2015-01-141070
K142793AbbVie PEGAbbVie , Inc.2015-01-141100
K133087ABBVIE PEGAbbVie , Inc.2014-06-192620
K133129ABBVIE NJAbbVie , Inc.2014-06-192620
K133096ABB VIE JAbbVie , Inc.2014-06-182610

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