Atlas FDA

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

N.M. Beale Co., Inc. · Predicate Candidate Screening

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

165 daysmedian FDA review time
470 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093584EZ-MISTERN.M. Beale Co., Inc.2011-03-044700
K093329SCOPE INTRODUCER MODEL 7400N.M. Beale Co., Inc.2010-02-161130
K071579PEF TUBEN.M. Beale Co., Inc.2007-11-201650
K992178BALLOON FOR ULTRASONIC ENDOSCOPESN.M. Beale Co., Inc.2000-05-123190
K903834N. M. BEALE COMPANY VU-THRU WATER BOTTLEN.M. Beale Co., Inc.1990-09-24340

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