Atlas FDA

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

Ercons, Inc. — Predicate Candidate Screening

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

126 daysmedian FDA review time
225 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990008ERCO-RIBBON -CErcons, Inc.1999-02-24510
K990006ERCO-VAC -CErcons, Inc.1999-02-24510
K981343ERCO-RIBBONErcons, Inc.1998-11-242250
K981357ERCO-VACErcons, Inc.1998-11-242240
K972537ERCO-VACErcons, Inc.1997-11-031180
K972353ERCO-RIBBONErcons, Inc.1997-10-281260

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